text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Wakefield and Pontefract Community Health National Health Service Trust (Transfer of Trust Property) Order 1994 and shall come into force on 29th September 1994.
2
In this Order —
“the Authority” means the Wakefield Health Authority;
“the Trust” means the Wakefield and Pontefract Community Health National Health Service Trust;
“the trust property” means the items specified in a schedule of trust property prepared by and agreed upon by the Authority and the Trust on 25th May 1994, which schedule has been signed on behalf of both the Authority and the Trust.
Transfer of trust property
2
On 29th September 1994 the trust property shall be transferred from the Authority to the Trust.
Signed by authority of the Secretary of State for Health.
Gerald Malone
Minister of State,
Department of Health
1st September 1994


type: legislation

jurisdiction: UK

text:
Citation and commencement
1
These Regulations may be cited as the Medical Devices Regulations 1994 and shall come into force —
a
for the purposes of regulation 17 on 21st December 1994; and
b
for all other purposes on 1st January 1995.
Interpretation
2
1
In these Regulations, unless the context requires otherwise —
“the 1987 Act ” means the Consumer Protection Act 1987;
“accessory” means an article which, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable the device to be used as intended by its manufacturer;
“Annex” means an Annex to the Directive , and a reference in these Regulations to a numbered Annex is to the Annex of the Directive which is so numbered;
“authorised representative” means an authorised representative established within the Community ;
“CE marking” means the marking which indicates that one or more of the procedures referred to in regulations 7, 8, 9, 10 and 11 has, or, as the case may be, have been followed and which consists of a symbol comprising the letters “CE” the form and dimensions of which are as specificed in Annex XII ;
“the Community” means the European Economic Area established under the EEA Agreement but until that Agreement comes into force in relation to Liechtenstein does not include the State of Liechtenstein;
“custom-made” means, in relation to a device —
that it is manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user which gives, under his responsibility, specific characteristics as to its design; and
that it is intended for the sole use of a particular patient,
but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;
“device” means a medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which —
is intended by the manufacturer to be used for human beings for the purpose of —
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process, or
control of conception; and
does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,
even if it is intended to administer a medicinal product as defined in Council Directive 65/65/ EEC or incorporates as an integral part a substance which, if used separately, would be a medicinal product as so defined and which is liable to act upon the body with action ancillary to that of the device;
“the Directive” means Council Directive 93/42/EEC concerning medical devices ;
“the EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993 ;
“ EEA State ” means a State which is a Contracting Party to the EEA Agreement but until the EEA Agreement comes into force in relation to Liechtenstein does not include the State of Liechtenstein;
“essential requirements” means the requirements specified in Annex I and “relevant essential requirements” in relation to a device means such of those requirements, or such aspects of those requirements, as apply to it, not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;
“harmonised Standard” means —
a technical specification adopted by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or both of them, upon a remit from the European Commission pursuant to Council Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Council Directive 88/182/EEC , Council Directive 90/320/EEC and European Parliament and Council Directive 94/10/ EC , and the reference of which has been published in the Official Journal of the European Communities; or
a monograph of the European Pharmacopoeia and in particular any monograph on surgical sutures or on interaction between medicinal products and materials used in devices containing medicinal products, the reference of which has been published in the Official Journal of the European Communities;
“intended for clinical investigation” means, in relation to a device, that it is intended for use by a duly qualified medical practitioner or a professional user when conducting investigations of that device in an adequate human clinical environment;
“intended purpose” means, in relation to a device, the use for which it is intended according to the data supplied by the manufacturer on the labelling, and —
the instructions;
the promotional materials; or
the instructions and the promotional materials;
“manufacturer” means the person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party;
“medical practitioner” means a registered medical practitioner;
“notified body” means, in relation to any task, a body designated and notified in respect of that task in accordance with Article 16 of the Directive;
“placing on the market” means, in relation to a device, the first making available in return for payment or free of charge of a new or fully refurbished device other than a device intended for clinical investigation, with a view to distribution, use, or both, on the Community market;
“putting into service” means, in relation to a device, making it ready for use on the Community market for the first time for its intended purpose;
“relevant national Standard” means, in relation to an essential requirement or an aspect of it, a Standard —
which contains a technical specification or a description relating to that requirement or aspect;
which corresponds to a harmonised Standard containing such a specification or description; and
of which the reference number is published in the United Kingdom by the Secretary of State by notice in the London, Edinburgh and Belfast Gazettes or in another member State;
“relevant notified body identification number” means the identification number of the notified body which was responsible for carrying out tasks of the notified body under Annex II , IV , V or VI as respects a procedure which has been followed by the manufacturer of a device;
“used for in vitro diagnosis” means, in relation to a device, that it is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination and that it is intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof,
and any other words and expressions used both in these Regulations and in the Directive shall bear the same meaning in these Regulations as they have in the Directive.
2
In these Regulations, unless the context requires otherwise, a reference to a numbered regulation is to the regulation of these Regulations which is so numbered, a reference in a regulation to a numbered paragraph is to the paragraph of that regulation which is so numbered, and a reference in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph of that paragraph which is so numbered or lettered.
Application of Regulations
3
1
Subject to paragraph (2), these Regulations shall apply to medical devices and their accessories and, for the purposes of these Regulations, accessories shall be treated as devices in their own right.
2
These Regulations shall not apply to —
a
devices used for in vitro diagnosis;
b
active implantable devices covered by Council Directive 90/385/EEC as amended by the Directive and by Council Directive 93/68/EEC ;
c
medicinal products covered by Council Directive 65/65/EEC as last amended by Council Directive 93/39/EEC ;
d
cosmetic products covered by Council Directive 76/768/EEC as last amended by Council Directive 93/47/EEC ;
e
human blood, human blood products, human plasma or blood cells of human origin or devices which incorporate at the time of placing on the market such blood products, plasma or cells;
f
transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin;
g
transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue; or
h
products whose principal intended purpose is such that they fall under Council Directive 89/686/EEC as amended by Council Directive 93/68/EEC .
3
Except for the purposes of regulation 5(2), these Regulations shall not apply to devices intended to administer a medicinal product within the meaning of Article 1 of Council Directive 65/65/EEC where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable.
4
References in subsequent provisions of these Regulations to devices are references to devices to which these Regulations apply in accordance with the preceding paragraphs of this regulation.
Classification of devices
4
1
For the purposes of these Regulations, devices are classified into Classes I, IIa, IIb and III in accordance with the definitions, implementing rules and classification rules set out in Annex IX.
2
In the event of a dispute between the manufacturer and a notified body resulting from the application of the definitions and rules referred to in paragraph (1), the matter shall be referred to the Secretary of State for decision.
Essential requirements for devices
5
1
Subject to paragraph (2), all devices placed on the market or put into service must comply with the relevant essential requirements.
2
The devices mentioned in regulation 3(3) which are placed on the market or put into service must comply with such of the relevant essential requirements as relate to safety or performance.
3
In determining which are the relevant essential requirements for a device and whether or not the device complies with any of the relevant essential requirements account shall be taken of its intended purpose.
4
Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.
5
In the case of a device which has been put into service —
a
the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and
b
the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if such instructions are in English or another Community language.
6
Where the instructions for use referred to in paragraph (5)(b) are not in English, any packaging, label or promotional literature must carry a clear statement in English stating the language in which the instructions are given.
7
A device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national Standard unless there are reasonable grounds for suspecting that the device does not comply with that requirement.
8
A device which is neither custom-made nor intended for clinical investigation and which bears the CE marking shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.
9
A custom-made device in respect of which the conditions specified in Annex VIII are satisfied, and in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII, shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.
10
A device intended for clinical investigation in respect of which —
a
notice has been given under regulation 16(1);
b
the conditions specified in Annex VIII are satisfied; and
c
either —
i
no notice has been given under regulation 16(2) within the period of 60 days there referred to, or
ii
notice has been given under regulation 16(3),
shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.
CE marking
6
1
Except as provided by paragraph (2), every device placed on the market shall bear the CE marking (affixed following a procedure mentioned in regulation 7, 8, 9, 10 or 11, whether carried out in the United Kingdom or elsewhere) in a visible, legible and indelible form —
a
on the device or its sterile pack, where practicable and appropriate;
b
on the instructions for use; and
c
where applicable, on the sales packaging,
and, where relevant, the marking shall be accompanied by the relevant notified body identification number.
2
Paragraph (1) shall not apply to a device which is custom-made or intended for clinical investigation.
3
No device shall bear a mark or inscription which is likely to mislead third parties with regard to the meaning or the graphics of the CE marking.
4
Any other mark may be affixed to a device, its packaging or accompanying instruction leaflet, provided that the visibility and legibility of the CE marking are not thereby reduced.
5
Where a device comes within the scope of a directive other than the Directive and that other directive provides for the affixing of the CE marking, the CE marking shall not be affixed unless the relevant requirements of that other directive are also satisfied.
6
Where a directive other than the Directive permits a manufacturer to choose which arrangements to apply during a transitional period, the CE marking shall indicate that the device fulfils only the provisions of those directives applied by the manufacturer.
7
In a case falling within paragraph (6), particulars of the directives applied by the manufacturer, as published in the Official Journal of the European Communities, shall be given in the documents, notices or instructions required by the directives and accompanying the device.
Procedure for affixing CE marking for Class I devices
7
A device falling within Class I may bear the CE marking only if its manufacturer follows the EC declaration of conformity procedure specified in Annex VII.
Procedure for affixing CE marking for Class IIa devices
8
A device falling within Class IIa may bear the CE marking only if its manufacturer —
a
follows the EC declaration of conformity procedure (full quality assurance system) set out in Annex II, excluding Section 4 of that Annex; or
b
follows the EC declaration of conformity procedure set out in Annex VII , together with —
i
the EC verification procedure set out in Annex IV,
ii
the EC declaration of conformity procedure (production quality assurance) set out in Annex V, or
iii
the EC declaration of conformity procedure (product quality assurance) set out in Annex VI.
Procedure for affixing CE marking for Class IIb devices
9
A device falling within Class IIb may bear the CE marking only if its manufacturer —
a
follows the EC declaration of conformity procedure (full quality assurance system) set out in Annex II, excluding Section 4 of that Annex; or
b
follows the EC type-examination procedure set out in Annex III, together with —
i
the EC verification procedure set out in Annex IV,
ii
the EC declaration of conformity procedure (production quality assurance) set out in Annex V, or
iii
the EC declaration of conformity procedure (product quality assurance) set out in Annex VI.
Procedure for affixing CE marking for Class III devices
10
A device falling within Class III may bear the CE marking only if its manufacturer —
a
follows the EC declaration of conformity procedure (full quality assurance system) set out in Annex II; or
b
follows the EC type-examination procedure set out in Annex III, together with —
i
the EC verification procedure set out in Annex IV, or
ii
the EC declaration of conformity procedure (production quality assurance) set out in Annex V.
Procedure for systems and procedure packs, and devices to be sterilised before use
11
1
Any person who puts together devices bearing the CE marking within their intended purpose and within the limits of use specified by their manufacturers in order to place them on the market as a system or procedure pack shall draw up a declaration that —
a
he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and he has carried out his operations in accordance with these instructions;
b
he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and
c
his operations are subjected to appropriate methods of internal control and inspection.
2
A system or procedure pack shall be treated as a device in its own right and shall be subjected to the relevant procedure under regulation 7, 8, 9 or 10 where —
a
it incorporates any device which does not bear a CE marking; or
b
the chosen combination of devices is intended to be put to a different use from any intended by the manufacturer of each device.
3
Any person who, for the purposes of placing on the market a system or procedure pack referred to in paragraph (2) or a CE marked medical device designed by its manufacturer to be sterilised before use, shall —
a
for the purposes of validating a sterilisation procedure, follow one of the procedures referred to in Annex IV, Annex V or Annex VI as it relates to the obtaining of sterility; and
b
make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.
4
A conformity assessment procedure carried out by a notified body in relation to a system or procedure pack or device referred to in paragraph (3) shall be limited to the procedures referred to in paragraph (3)(a).
5
A system or procedure pack solely made up of devices bearing the CE marking —
a
shall not bear an additional CE marking; and
b
shall be accompanied by the information referred to in Section 13 of Annex I which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.
6
The declaration referred to in paragraphs (1) and (3)(b) shall be kept available for the Secretary of State for a period of five years.
General provisions relating to conformity assessment procedures
12
1
A notified body which is responsible for carrying out a conformity assessment procedure in connection with a device under regulation 7, 8, 9, 10 or 11 shall, in doing so, take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out under the laws or administrative provisions in force before 1st January 1995 in any EEA State.
2
Any manufacturer of a device or any notified body shall, in carrying out a conformity assessment procedure for affixing the CE marking to a device, take account of the results of any assessment or verification operations which have been carried out in accordance with the Directive or these Regulations at an intermediate stage of manufacture of the device.
3
Any procedure set out in Annex III, IV, VII or VIII which, by virtue of these Regulations, is to be followed in the United Kingdom by a manufacturer who has no place of business there may be initiated there by his authorised representative.
4
Where a conformity assessment procedure involves the intervention of a notified body, the manufacturer of a device or his authorised representative may apply to any notified body which has been designated in accordance with Article 16 of the Directive to carry out tasks in respect of that type of device for the purposes of that conformity assessment procedure.
5
Where a manufacturer has supplied information or data to a notified body in the course of a conformity assessment procedure, the notified body may require the manufacturer to provide any additional information or data which the notified body considers necessary for the purposes of that procedure.
6
A decision made by a notified body in accordance with Annex II or Annex III shall —
a
specify the period of validity of the decision; and
b
be valid for an initial period of not more than 5 years.
7
Where an agreement under which a notified body agrees to carry out a conformity assessment procedure for a manufacturer allows the manufacturer to apply to the notified body at a specified time for an extension of the period of validity of a decision mentioned in paragraph (6), the notified body may extend the validity of the decision for further periods of 5 years, each such period commencing on the expiry of the preceding period.
8
The documentation relating to any of the procedures referred to in this regulation carried out in the United Kingdom shall be in English or, subject to regulation 5(5) and (6), in some other language acceptable to the notified body concerned.
9
Where the procedures referred to in regulation 7, 8, 9, 10 or 15 have not been carried out in relation to an individual device, the Secretary of State may authorise the placing on the market and putting into service of that device if she is satisfied that this would be in the interest of protection of health.
10
A manufacturer shall, in following a conformity assessment procedure, observe the manufacturer’s obligations set out in the Annex on that procedure.
11
In so far as a conformity assessment procedure relates to tasks to be carried out by a notified body, that body shall carry out the notified body’s tasks set out in the Annex on that procedure and shall do so in accordance with that Annex.
Obligations of persons other than manufacturers
13
1
Subject to paragraph (2), any obligation of a manufacturer under these Regulations shall extend to a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.
2
Paragraph (1) shall not apply to a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.
3
Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in Section 6.3 of Annex II or Section 7.4 of Annex III shall fall upon the person responsible for placing on the market the device to which the documentation relates or upon the importer referred to in Section 13.3(a) of Annex I.
4
Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in Section 2 of Annex VII shall fall upon the person who places on the market the device to which the documentation relates.
Registration of persons placing devices on the market
14
1
A manufacturer with a registered place of business in the United Kingdom who, under his own name, places a device on the market in accordance with the procedures referred to in regulation 7 or regulation 15(1) shall —
a
inform the Secretary of State of the address of that registered place of business; and
b
supply the Secretary of State with a description of each category of device concerned.
2
Any person with a registered place of business in the United Kingdom who is engaged in the activities referred to in regulation 11 shall —
a
inform the Secretary of State of the address of that registered place of business; and
b
supply the Secretary of State with descriptions of the devices to which that regulation applies which are sufficient to identify them.
3
Any person with a registered place of business in the United Kingdom who places on the market a device referred to in paragraph (1) on behalf of a manufacturer who does not have a registered place of business in the Community shall inform the Secretary of State of —
a
the address of his registered place of business; and
b
the category of device.
Custom-made devices
15
1
Before a custom-made device is placed on the market its manufacturer shall —
a
draw up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII;
b
undertake to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations; and
c
take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII.
2
The information contained in the statement referred to in paragraph (1)(a) and in the undertaking referred to in paragraph (1)(b) shall be kept available for a minimum period of 5 years.
Clinical investigations
16
1
Before devices intended for clinical investigation are made available to a medical practitioner or authorised qualified person for the purposes of a clinical investigation to take place within the United Kingdom, their manufacturer or his authorised representative shall give at least 60 days' prior notice in writing to the Secretary of State of the making available of the devices for the intended investigation, in the form of —
a
the statement required by Sections 1, 2 and 2.2 of Annex VIII; and
b
the undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII.
2
If, within 60 days of the giving of that notice, the Secretary of State gives written notice to the manufacturer or authorised representative, whichever gave the notice to her under paragraph (1), that, on grounds of public health or public policy, devices should not be made available for the purposes of that investigation, devices may not be made available for those purposes pursuant to that notice under paragraph (1).
3
Where the relevant ethics committee has issued a favourable opinion on a programme of clinical investigation, the Secretary of State may give written notice to the manufacturer or his authorised representative within 60 days of the giving of notice under paragraph (1) that devices may be made available for the purposes of that investigation at any time after the giving of notice under that paragraph.
4
The manufacturer of a device intended for clinical investigation shall —
a
take all necessary measures to ensure that the manufacturing process ensures that a device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.2 of Annex VIII; and
b
authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.
5
The manufacturer or his authorised representative shall —
a
keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X; and
b
keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of 5 years.
6
Clinical investigations shall be conducted in accordance with the provisions of Annex X.
7
Paragraphs (1), (2) and (3) do not apply where clinical investigations are conducted using devices which are authorised in accordance with regulation 7, 8, 9 or 10 to bear the CE marking unless the aim of those investigations is to determine whether the device in question may be used for a purpose other than that referred to in the relevant conformity assessment procedure.
8
The grounds on which a notice may be given under paragraph (2) include the grounds that the Secretary of State is not satisfied as to the safety of a device for the intended purposes because —
a
the manufacturer does not authorise an assessment by the Secretary of State, whether by means of an audit, and inspection or otherwise, of the effectiveness of the measures referred to in paragraph (4); or
b
the manufacturer or his authorised representative does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).
Notified bodies
17
1
The Secretary of State may designate for the purposes of Article 16 of the Directive any corporate or other body as a body which is to carry out tasks as part of a procedure mentioned in regulation 7, 8, 9, or 10 and, if she so designates a body, she shall designate the tasks which it is to carry out.
2
A body shall be designated under paragraph (1) only if —
a
it has applied to be, or agrees to be, so designated; and
b
it is a body in respect of which the conditions specified in Annex XI are fulfilled as respects the tasks which it is to carry out.
3
The Secretary of State shall withdraw any designation of a body under paragraph (1) if the body so requests or if she considers that it is no longer a body in respect of which the conditions specified in Annex XI are fulfilled as respects the tasks which it is to carry out.
4
The Secretary of State may vary the designation of tasks which a notified body is to carry out by —
a
limiting or removing the tasks; or
b
on the application of the notified body, extending or adding to the tasks.
5
The Secretary of State may refuse to designate a body as a notified body, or may withdraw designation of a body as a notified body if it fails to pay any fee or other charge in accordance with regulations made under section 56 of the Finance Act 1973 in connection with services provided by the Secretary of State in carrying out her functions as competent authority for the purposes of the Directive.
6
Before withdrawing designation under paragraph (3), otherwise than at the notified body’s request, and before effecting a variation under paragraph (4)(a), the Secretary of State shall give to the notified body an opportunity to make representations to her in writing and shall take into account any such representations as are made.
7
For the purpose of deciding whether or not a body is one in respect of which the conditions specified in Annex XI are fulfilled as respects the tasks which it carries out or is to carry out, the Secretary of State may arrange for the inspection of —
a
any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or
b
any premises occupied, or plant or equipment used, by a manufacturer where the body is a notified body undertaking any task in relation to that manufacturer,
and may take into account for the purposes of her decision any refusal of reasonable facilities for such inspection and the results of any such inspection.
Prohibition on supply etc.
18
1
Subject to paragraph (6) the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device, which constitutes placing on the market or putting into service a device which does not comply with the relevant essential requirements, is prohibited.
2
Subject to paragraphs (3) and (6), the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device —
a
which does not bear the CE marking as required by regulation 6(1); or
b
which bears a mark in contravention of regulation 6(3),
is prohibited.
3
Paragraph (2)(a) does not apply to a device which is custom-made or intended for clinical investigation.
4
The supply of a custom-made device in respect of which the manufacturer has contravened regulation 15 is prohibited.
5
The supply, in contravention of regulation 16(1) or a notice under regulation 16(2), of a device intended for clinical investigation is prohibited.
6
Nothing in paragraphs (1) or (2) prevents the offer to supply, the exposure for supply or the possession for supply at a trade fair, exhibition, demonstration or similar event of a device which does not comply with the relevant essential requirements or which does not bear the CE marking, provided that a notice is prominently displayed at the event, so as to be readily visible to a prospective purchaser, indicating that the device —
a
does not comply with those requirements or does not bear that marking; and
b
may not be put into service until it complies with the requirements of the Directive.
Enforcement etc.
19
1
Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act, these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings or notices or otherwise) and for the purposes of section 38 of that Act (disclosure of information) as safety regulations as defined in that Act and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act.
2
Except as provided by paragraph (3), each weights and measures authority in Great Britain and each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to devices, and that duty is transferred to the Secretary of State.
3
Paragraph (2) shall not relieve an authority or council of its duty in relation to devices which are consumer goods for the purposes of Part II of the 1987 Act and accordingly each weights and measures authority in Great Britain and each district council in Northern Ireland shall, concurrently with the Secretary of State, enforce these Regulations in relation to such devices.
4
Each authority and council referred to in paragraph (3) on whom a duty is imposed by section 27(1) of the 1987 Act to enforce the provisions of these Regulations shall give immediate notice to the Secretary of State of —
a
any suspension notice served by it under section 14 of that Act in respect of a device to which paragraph (3) applies;
b
any application made by it under section 16 of that Act for an order for forfeiture of any such device; and
c
any other thing done by it in respect of such a device for the purposes of, or in connection with the operation of, sections 14 to 17 of that Act.
5
The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non-conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to such goods), and in relation to non-conforming devices Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to devices being or not being non-conforming devices.
6
In paragraph (5) “non-conforming devices” means devices which, whether or not the Secretary of State considers them unsafe, she considers to be devices to which the CE marking has been wrongly applied and to be devices —
a
which do not conform as respects a relevant essential requirement to a relevant national Standard where the device is held out as respects that essential requirement as conforming to that Standard;
b
where the devices are ones to which the CE marking has been applied following the EC declaration of conformity procedure, in respect of which the manufacturer or his authorised representative has failed to comply with his obligations under that procedure; or
c
where the devices are ones to which the CE marking has been applied following the EC type-examination procedure, which do not conform to the type described in the relevant EC type-examination certificate or which conform to such a type which does not meet the relevant essential requirements.
7
Except in the case of a device which in the opinion of an enforcement authority is likely to compromise the health or safety of any person, where an enforcement authority has reasonable grounds for suspecting that the CE marking has been affixed to any device in relation to which any provision of these Regulations has not been complied with, that authority may serve upon the manufacturer or his authorised representative a notice —
a
specifying the description of the device to which the notice relates;
b
stating that the enforcement authority suspects that the CE marking has been affixed to the device in circumstances where a provision of these Regulations has not been complied with and the reasons for that suspicion;
c
specifying the provision referred to in sub-paragraph (b);
d
requiring the person on whom the notice is served —
i
to secure that any device to which the notice relates conforms as regards the provision concerning the CE marking within such period as may be specified in the notice, or
ii
to provide evidence within that period to the satisfaction of the enforcement authority that all the provisions of these Regulations have been complied with so far as they relate to that device; and
e
warning the person on whom the notice is served that unless the requirements of sub-paragraph (d) are met, further action may be taken under these Regulations in respect of that device or any device of the same type supplied by that person.
8
Where an enforcement authority serves a notice referred to in paragraph (7), section 14, 16 or 17 of the 1987 Act shall not be applied as respects any device to which the notice relates until the period referred to in paragraph (7)(d) has expired and unless at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.
9
The notice referred to in paragraph (7) may include directions as to the measures to be taken by the person on whom the notice is served to secure conformity of the device with the provisions of these Regulations including different ways of securing conformity; and any such directions as are included are requirements of the notice for the purposes of paragraph (8).
Centralised system of records etc.
20
The Secretary of State shall perform, as respects the United Kingdom, the functions of the member State under Article 10 of the Directive.
Fees
21
1
A notified body may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with, performing a function required by or under any of the Annexes referred to in regulations 7, 8, 9, 10 and 11 to be performed by a notified body.
2
Except as provided by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.
3
Where the notified body is a body the activities of which are carried on for profit, the fee for doing anything may include an amount representing a profit which is reasonable in the circumstances, having regard to —
a
the character and extent of the work done or to be done by the notified body; and
b
the commercial rate normally charged in respect of profit for that work or similar work.
4
The notified body may require payment of a fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.
Transitional provisions
22
1
Nothing in regulation 18(1), (2) or (4) —
a
shall prohibit the supply before 14th June 1998 of a device, if the supply of the device is in accordance with the laws of that part of the United Kingdom in which it is supplied as in force on 31st December 1994; or
b
shall prohibit the supply before 1st July 2004 of a device which has been subjected to EEC pattern approval before 1st January 1995 in accordance with the Clinical Thermometers (EEC Requirements) Regulations 1993 .
2
In paragraph (1) “supply” means the supply, offer to supply, agreement to supply, exposure for supply or possession for supply.
Notification of decisions etc.
23
1
Where a decision is taken by the Secretary of State or a notified body under these Regulations which results in the refusal of, or restrictions on, the placing on the market by, or the putting into service by, or the carrying out of clinical investigations by a person of a device, the Secretary of State who, or the notified body which, took the decision shall forthwith give to that person notice of the decision which shall include —
a
a statement of the grounds on which it is based; and
b
a statement of any legal remedies available to that person and of any time limits which apply to their exercise.
2
The provisions of paragraph (1) are in addition to any more specific obligation placed upon the Secretary of State or the notified body elsewhere in these Regulations.
3
Except in cases of emergency, the Secretary of State or a notified body which is considering making a decision referred to in paragraph (1), shall give the manufacturer or his authorised representative an opportunity to make representations to her or it (as the case may be) before the decision is taken.
Amendment of Schedule 1 to the Provision and Use of Work Equipment Regulations 1992
24
In Schedule 1 to the Provision and Use of Work Equipment Regulations 1992 there shall be added the following paragraph —
36
Council Directive 93/42/EEC concerning medical devices ( OJ No. L169, 12.7.1993 p.1).
.
Substitution for Schedule 1 to the Personal Protective Equipment at Work Regulations 1992
25
For Schedule 1 to the Personal Protective Equipment at Work Regulations 1992 there shall be substituted the following Schedule —
SCHEDULE 1
RELEVANT COMMUNITY DIRECTIVES
Regulation 4(3)(e)
1
Council Directive 89/686/EEC on the approximation of the laws of the member States relating to personal protective equipment (OJ No. L399, 30.12.89, p.18).
2
Council Directive 93/42/EEC concerning medical devices (OJ No. L169, 12.7.93, p.1).
.
Amendment of the Clinical Thermometers (EEC Requirements) Regulations 1993
26
1
The Clinical Thermometers (EEC Requirements) Regulations 1993 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 5 after the word “approval” there shall be inserted the words “granted before 1st January 1995”.
3
For paragraph (1) of regulation 6 there shall be substituted the following paragraph —
1
On application made by the body, the Secretary of State may approve one or more bodies of persons to carry out EEC initial verification and to affix the EEC mark of initial verification in respect of clinical thermometers.
.
4
In regulation 7 for the words from “Regulations 8 to 11 of the 1988 Regulations” to “and Schedule 2 to, the 1988 Regulations” there shall be substituted the words “Regulation 11 of the 1988 Regulations (which contains provisions with respect to the revocation of EEC pattern approval) shall apply in relation to the revocation of pattern approval of clinical thermometers to which these Regulations apply as they apply in relation to the revocation of pattern approval of instruments to which those Regulations apply as if in regulation 11 of the 1988 Regulations”.
Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988
27
1
The Electro-medical Equipment (EEC Requirements) Regulations 1988 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 2 (interpretation) —
a
for the definition of “the Directive” there shall be substituted the following definition —
“the Directive” means Council Directive 84/539/EEC on the approximation of the laws of the member States relating to electro-medical equipment used in veterinary medicine ;
;
b
in the definition of “electro-medical equipment” the words “human or” shall be omitted.
3
For regulation 3 (marking) there shall be substituted the following regulation —
3
A person shall be guilty of an offence where he supplies electro-medical equipment —
a
which does not comply with the technical requirements contained in Annex I to the Directive; and
i
which is marked with the reversed epsilon, (or with a mark so closely resembling it as to be taken to be the reversed epsilon), or
ii
to which a declaration has been applied; or
b
which is also a medical device for the purposes of the Medical Devices Regulations 1994 and which does not satisfy the essential requirements for that device specified in those Regulations.
.
Virginia Bottomley
One of Her Majesty’s Principal Secretaries of State
22nd November 1994
F. A. Elliott
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this
F. A. Elliott
Permanent Secretary
28th day of November 1994.


text:
Citation and commencement
1
This Order may be cited as the London Docklands Development Corporation (Alteration of Boundaries) Order 1994 and shall come into force on 31st October 1994.
Interpretation
2
In this Order —
“ the authority ” means the council of the London borough of Southwark;
“ the development area ” means the area designated as an urban development area by the London Docklands Development Corporation (Area and Constitution) Order 1980 ;
“ the development corporation ” means the London Docklands Development Corporation;
“ the excluded area ” means the area shown on the map bounded externally by a red line;
“the map” means the map entitled “Map referred to in the London Docklands Development Corporation (Alteration of Boundaries) Order 1994”, of which one print, signed by an Under Secretary in the Department of the Environment, has been deposited and is available for inspection at the offices of each of the Secretary of State for the Environment, the London Docklands Development Corporation and the councils of the London boroughs of Newham, Southwark and Tower Hamlets; and
“the 1990 Act ” means the Town and Country Planning Act 1990 .
Alteration of development area
3
Subject to the following provisions of this Order, the boundaries of the development area shall be altered so as to exclude the excluded area and, as regards any matter arising after the coming into force of this Order, any reference in an enactment to the development area shall be a reference to that area as it has been altered by this Order.
Transitional provisions in connection with article 3
4
The development corporation may continue to exercise the powers conferred on it by section 136 of the Local Government, Planning and Land Act 1980 —
a
to hold, manage, reclaim or dispose of —
i
any land in the excluded area owned by it at the coming into force of this Order; and
ii
any other property owned by it in connection with such land;
b
to discharge any obligation, exercise any right, power or privilege or assign any benefit under any agreement entered into by it in connection with the excluded area before the coming into force of this Order; and
c
until 31st March 1995, to give financial assistance in connection with activities within the excluded area to any person to whom such assistance was given before the coming into force of this Order,
and such powers shall be exercised as if the excluded area continued to form part of the development area.
Transitional provisions in connection with planning functions
5
1
This article applies as respects any application for planning permission or approval of reserved matters or for any other approval, consent or determination under the 1990 Act, or the Planning (Conservation Areas and Listed Buildings) Act 1990, or under any order or regulations made or having effect under either of those Acts which —
a
in the case of an application for approval of reserved matters, is duly made before 31st March 1995 to the development corporation in relation to land within the excluded area; or
b
in any other case, before this Order came into force was duly made to the development corporation in relation to land within the excluded area,
and has not been determined on the coming into force of this Order.
2
Except where the development corporation transmits the application to the authority for determination, the development corporation shall have in relation to an application the same powers and duties as it would have had if this Order had not come into force.
3
The development corporation shall transmit to the authority for determination —
a
any application which it has resolved with the agreement of the applicant to transmit to the authority; and
b
any other application which it has not determined on or before 31st March 1995.
4
Where the development corporation transmits an application to the authority for determination in accordance with paragraph (3), the application shall be accompanied by a copy of any representation received by the development corporation concerning the application and shall be treated as received by the authority from the applicant on the day on which it is transmitted to the authority.
5
Where an appeal is made to the Secretary of State under section 78 of the 1990 Act or section 20 of the Planning (Conservation Areas and Listed Buildings) Act 1990 in relation to an application to which this article applies, the authority shall be the local planning authority for the purposes of the appeal.
Liability for compensation in connection with planning functions and planning obligations
6
1
Where a right to compensation arises under sections 107 , 108 , 115, 186 , 203 or 204 of the 1990 Act or sections 28 or 29 of the Planning (Conservation Areas and Listed Buildings) Act 1990 in consequence of action taken in relation to land within the excluded area by the development corporation, the development corporation shall be liable for any compensation which is payable.
2
Where the Secretary of State makes an order or serves a notice, as the case may be, under section 100 , 104, 185 or 202 of, or paragraph 11 of Schedule 9 to, the 1990 Act in respect of a matter arising before this Order comes into force, which relates to land within the excluded area, the development corporation shall be liable to pay any compensation arising from the order or notice.
3
A planning obligation entered into by agreement or otherwise under section 106 of the 1990 Act in relation to land within the excluded area which identifies the development corporation as the local planning authority by whom the obligation is enforceable shall be enforceable by the authority.
Signed by authority of the Secretary of State for the Environment
Paul Beresford
Parliamentary Under–Secretary of State,
Department of the Environment
1st October 1994


text:
Citation and commencement
1
This Order may be cited as the National Health Service Act 1977 (Composition of Medical Practices Committee) Modification Order 1994 and shall come into force on 1st April 1994.
Modification of section 7(1)(b) of the National Health Service Act 1977
2
In section 7(1) of the National Health Service Act 1977 (composition of Medical Practices Committee) paragraph (b) shall be modified by substituting “five of the” for “the chairman and five of the other”.
Signed by authority of the Secretary of State for Health
Brian Mawhinney
Minister of State,
Department of Health
4th March 1994


text:
1
These Regulations may be cited as the Merchant Shipping (IBC Code) (Amendment) Regulations 1994 and shall come into force on 1st September 1994.
2
The Merchant Shipping (IBC Code) Regulations 1987 are hereby amended as follows.
3
In regulation 1(3) —
a
in the definition of “IBC Code” for “(1990 Edition)” there shall be substituted “(1994 Edition)”;
b
for the definition of “1974 SOLAS Convention” there shall be substituted the following —
“ 1974 SOLAS Convention ” means the International Convention for the Safety of Life at Sea as amended by:
the Protocol of 1978 ; and
amendments adopted by the Maritime Safety Committee of the International Maritime Organization on:
20th November 1981;
17th June 1983;
21st April, 28th October, and 9th and 10th November 1988;
11th April 1989;
25th May 1990;
23rd May 1991;
.
4
For regulation 1(4)(d) there shall be substituted the following —
d
any reference to the 1974 SOLAS Convention shall be construed as a reference to that Convention as defined in these Regulations.
.
5
After paragraph (4) of regulation 1 there shall be inserted the following paragraph —
5
Any reference in these Regulations to any of the following —
a
Code for the Construction and Equipment of Ships Carrying Dangerous Goods in Bulk;
b
International Code for the Construction and Equipment of Ships Carrying Dangerous Goods in Bulk;
c
International Code for the Construction and Equipment of Ships Carrying Liquefied Gases in Bulk;
d
MARPOL 1973/78;
e
1974 SOLAS Convention;
shall include a reference to any document amending it which is considered by the Secretary of State to be relevant from time to time and is specified in a Merchant Shipping Notice.
.
6
In regulation 3, after “and 19” there shall be inserted “and 20”.
7
The text in regulation 7 shall become paragraph (1), and the following paragraph shall be added —
2
For the purposes of these Regulations, the results of a verification or test shall be accepted if the verification or test is carried out by a body or laboratory in a member State other than the United Kingdom offering suitable and satisfactory guarantees of technical and professional competence and independence.
.
8
In regulation 10, for the words “£1,000” in both places where they occur there shall be substituted the words “the statutory maximum”.
9
The Schedule shall be omitted.
Signed by the authority of the Secretary of State for Transport
Goschen
Parliamentary Under Secretary of State
Department of Transport
4th August 1994


text:
Citation and commencement
1
These Regulations may be cited as the Pupils' Registration (Amendment) Regulations 1994 and shall come into force on 1st September 1994.
Amendment of the Pupils' Registration Regulations 1956
2
Regulation 3 of the Pupils' Registration Regulations 1956 shall be amended by —
a
the insertion at the end of paragraph (7) of —
; or
d
in the case of a pupil who is registered as a pupil at more than one school in accordance with regulation 4A below, because he is attending another school at which he is a registered pupil
, and
b
the insertion at the end of paragraph (8) of “or, in the case of a pupil who is registered as a pupil at more than one school in accordance with regulation 4A below, because he is attending another school at which he is a registered pupil”.
3
There shall be substituted for regulation 4 of those Regulations —
Deletions from Admission Register
4
1
The following grounds are hereby prescribed as those on which the name of a pupil of compulsory school age is to be deleted from the Admission Register —
a
where the pupil is registered at the school in accordance with the requirements of a school attendance order, that another school is substituted for that named in the order or the order is revoked on the ground that arrangements have been made for the child to receive efficient full-time education suitable to his age, ability and aptitude otherwise than at school;
b
except as provided in regulation 4A below, in a case not falling within sub-paragraph (a) of this paragraph, that he has been registered as a pupil of another school;
c
in a case not falling within sub-paragraph (a) of this paragraph, that he has ceased to attend the school at which he is registered and his parent has satisfied the Authority that he is receiving efficient full-time education suitable to his age, ability and aptitude otherwise than by attendance at school;
d
except in the case of a boarder, that his ordinary residence has been transferred to a place whence the school at which he is registered is not accessible with reasonable facility;
e
that he is certified by the school medical officer as unlikely to be in a fit state of health to attend school before becoming legally exempt from the obligation so as to attend;
f
that he has been continuously absent from school for a period of not less than four weeks and the proprietor of the school has failed, after reasonable enquiry, to obtain information of the cause of absence;
g
that the proprietor has ascertained that the pupil had died;
h
that he will cease to be of compulsory school age before the school next meets and intends to discontinue in attendance thereat;
i
in the case of a boarder, or of a pupil at a school other than a maintained school, that he has ceased to be a pupil of the school;
j
where the pupil is registered at a maintained school, that he has been permanently excluded from the school; or
k
having been admitted to the school for nursery education, he has not on completing such education transfered to a reception class at the school:
Provided that in a case not covered by sub-paragraph (a), (g) or (j) of this paragraph, or regulation 4A below, the name of a child who has under arrangements made by an Authority become a registered pupil at a special school shall not be removed from the Admission Register of that school without the consent of that Authority or, if that Authority refuse to give consent, without a direction of the Secretary of State.
2
The following grounds are hereby prescribed as those on which the name of a pupil not of compulsory school age is to be deleted from the Admission Register —
a
that he has ceased to attend the school, or, in the case of a boarder, that he has ceased to be a pupil of the school;
b
that he has been continuously absent from the school for a period of not less that four weeks and the proprietor of the school has failed, after reasonable enquiry, to obtain information of the cause of absence;
c
that the proprietor has ascertained that the pupil has died;
d
having been admitted to the school for nursery education, he has not on completing such education transferred to a reception class at the school; or
e
where the pupil is registered at a maintained school, that he has been permanently excluded from the school.
3
For the purposes of this regulation —
a
“maintained school” means a school maintained by an Authority, a grant-maintained school or a grant-maintained special school;
b
“reception class” means a class in which education is provided which is suitable to the requirements of pupils aged five and any pupils under or over the age whom it is expedient to educate together with pupils of that age;
c
children are to be regarded as having been admitted to a school for nursery education if they were placed on admission in a nursery class; and
d
the permanent exclusion of a pupil does not take effect until —
i
any review under the articles of government of the decision to exclude him has been completed, and
ii
either any time for appealing under section 26 of the Education ( No. 2) Act 1986 or those articles has expired without such an appeal being made or such an appeal has been finally concluded.
.
4
There shall be inserted after regulation 4 of those Regulations —
4A
1
Where a pupil is registered as a pupil at a pupil referral unit and at a school other than a pupil referral unit, the name of that pupil shall not be removed from the Admission Register of either the unit or the school in accordance with paragraph (1)(b) of regulation 4 above without the consent of both the Authority by which the unit is maintained and the proprietor of the school.
2
Subject to paragraph (3) of this regulation, where a pupil —
i
is registered as a pupil at a special school (including a special school established in a hospital) and at another school (other than a pupil referral unit), and
ii
there is not maintained for that pupil a statement of special educational needs specifying the name of the special school only,
the name of that pupil shall not be removed from the Admission Register of either school in accordance with paragraph (1)(b) of regulation 4 above without the consent of the proprietors of both schools.
3
Where a pupil is registered as a pupil at a special school established in a hospital and at another special school the name of that pupil shall not be removed from the Admission Register of either school in accordance with paragraph (1)(b) of regulation 4 above without the consent of the proprietors of both schools.
4
The requirements to obtain consent in paragraphs (1) to (3) above do not apply in cases covered by paragraph (1)(g) and (j) of regulation 4 above.
5
In this regulation, “special school” has the meaning assigned to it by section 182(1) of the Education Act 1993.
.
5
Regulation 7 of those Regulations shall be amended by the substitution for the proviso of the following —
Provided that this Regulation shall not have effect with respect to —
any absence from the school due to sickness of the pupil in respect of which a medical certificate has been furnished to the head teacher, or
any absence from the school of a pupil who is registered at more than one school in accordance with regulation 4A above, due to that pupil attending another school at which he is a registered pupil.
.
Eric Forth
Minister of State,
Department for Education
4th August 1994.
Gwilym Jones
Parliamentary Under Secretary of State, Welsh Office
10th August 1994.


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Great Ormond Street Hospital for Children National Health Service Trust (Establishment) Order 1994 and shall come into force on 21st March 1994.
2
In this Order unless the context otherwise requires —
“ the Act ” means the National Health Service and Community Care Act 1990;
“establishment date” means 21st March 1994;
“operational date” has the meaning assigned to it in paragraph 3(1)(e) of Schedule 2 to the Act;
“the trust” means the Great Ormond Street Hospital for Children National Health Service Trust established by article 2 of this Order.
Establishment of the trust
2
There is hereby established an NHS trust which shall be called the Great Ormond Street Hospital for Children National Health Service Trust.
Nature and functions of the trust
3
1
The trust is established for the purpose specified in section 5(1)(a) of the Act.
2
The trust’s functions (which include functions which the Secretary of State considers appropriate in relation to the provision of services by the trust for one or more health authorities) shall be to own and manage hospital accommodation and services provided at Hospital for Sick Children, Great Ormond Street, London WC1N 3JH and associated hospitals (including the management of its teaching and research facilities).
Directors of the trust
4
1
The trust shall have, in addition to the chairman, 5 non-executive directors and 5 executive directors.
2
Since the trust is to be regarded as having a significant teaching commitment within the meaning of paragraph 3(1)(d) of Schedule 2 to the Act, one of the non-executive directors shall be appointed from London University.
Operational date and accounting date of the trust
5
1
The operational date of the trust shall be 1st April 1994.
2
The accounting date of the trust shall be 31st March.
Limited functions before operational date
6
Between its establishment date and its operational date the trust shall have the functions —
a
of entering into NHS contracts;
b
of entering into other contracts, including contracts of employment; and
c
of doing such other things as are reasonably necessary to enable it to begin to operate satisfactorily with effect from its operational date.
Assistance by health authorities before operational date
7
1
The Board of Governors of the Hospitals for Sick Children shall —
a
until the operational date, make such staff and facilities available to the trust as are required to enable the trust to carry out its limited functions pending the transfer or appointment of staff to or by the trust and the transfer of facilities to the trust;
b
make available such premises as are required to enable the trust to carry out its limited functions pending the transfer of premises to the trust.
2
The Board of Governors of the Hospitals for Sick Children shall discharge the liabilities of the trust, incurred between the establishment date and the operational date, that are of a description specified in paragraph (3) of this article.
3
The liabilities referred to in the preceding paragraph are —
a
liability for the remuneration and travelling or other allowances of he chairman and non-executive directors of the trust;
b
liability for the travelling or other allowances of the members of committees and sub-committees of the trust who are not also directors of the trust;
c
liability for the remuneration of persons employed by the trust; and
d
any other liability which may reasonably be incurred by the trust for the purpose of enabling it to begin to operate satisfactorily with effect from its operational date.
4
The health authority specified for the purposes of paragraph 3(1)(f) of Schedule 2 to the Act (authority which is to make the scheme under section 6 of the Act for the transfer of staff) in relation to the trust shall be the Board of Governors of the Hospitals for Sick Children.
Restriction on disposal of assets
8
The sum specified for the purposes of paragraph 6(2)(d) of Schedule 2 to the Act (maximum value of freely disposable assets) in relation to the trust shall be £1,000,000.
Signed by authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State
Department of Health
23rd February 1994


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Food Protection (Emergency Prohibitions) (Radioactivity in Sheep) Partial Revocation Order 1994 and shall come into force on 19th January 1994.
2
In this Order “the principal Order ” means the Food Protection (Emergency Prohibitions) (Radioactivity in Sheep) Order 1991 .
Partial revocation
2
1
The principal Order is revoked so far as it designates any part of the areas set out in Schedule 1 to this Order.
2
Part II of Schedule 1 to the principal Order shall be amended in accordance with Schedule 2 to this Order.
J N Randall
Assistant Secretary, Scottish Office
St Andrew’s House,
Edinburgh
13th January 1994


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Halton General Hospital National Health Service Trust (Transfer of Trust Property) Order 1994 and shall come into force on 31st May 1994.
2
In this Order —
“the Authority” means the North Cheshire Health Authority;
“the Trust” means the Halton General Hospital National Health Service Trust;
“the trust property” means the items specified in a schedule of trust property prepared by and agreed upon by the Authority and the Trust on 3rd March 1994, which schedule has been signed on behalf of both the Authority and the Trust.
Transfer of trust property
2
On 31st May 1994 the trust property shall be transferred from the Authority to the Trust.
Signed by authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State,
Department of Health
3rd May 1994


text:
1
This Order may be cited as the Public Telecommunication System Designation (Videotron City and Westminster Limited) Order 1994 and shall come into force on 28th April 1994.
2
Each of the Applicable Systems is hereby designated as a public telecommunication system.
Neil Hamilton
Parliamentary Under Secretary of State
Department of Trade and Industry
24th March 1994


text:
1
1
This Order may be cited as the Drug Trafficking Offences Act 1986 (Designated Countries and Territories) (Amendment) Order 1994 and shall come into force on 1st August 1994.
2
In this Order “ the Act ” means the Drug Trafficking Offences Act 1986 and “the principal Order ” means the Drug Trafficking Offences Act 1986 (Designated Countries and Territories) Order 1990 .
2
Schedule 1 to the principal Order shall be amended as follows —
a
by the insertion, at the appropriate places in alphabetical order, of the entries for those countries and territories specified in the Schedule to this Order (including where so specified the appropriate authority for a country or territory); and
b
by the removal of the entry relating to Czechoslovakia.
3
The Appendix set out at the end of Schedule 3 to the principal Order (which defines the institution of proceedings for the purposes of paragraph (a) of section 38(11) of the Act as modified by Schedule 2 to the principal Order) shall be amended by the insertion, after the entry relating to Bermuda, of the following —
British Virgin Islands
a
when a summons or warrant is issued in respect of an offence;
b
when a person is charged with an offence after being taken into custody without a warrant;
c
when an indictment is preferred
N. H. Nicholls
Clerk of the Privy Council


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the National Health Service (Determination of Regions) Order 1994 and shall come into force on 1st April 1994.
2
In this Order —
“ the Act ” means the National Health Service Act 1977;
“the material date” means 1st April 1994;
“the new authorities” means the Regional Health Authorities specified in column (2) of Schedule 2 to the National Health Service (Regional Health Authorities) Order 1994 being in each case an authority established by that Order;
“the old authorities” means the Regional Health Authorities specified in Schedule 1 to that Order, being in each case an authority abolished by that Order;
“the relevant new authority” means —
as respects any old authority specified in column (1) of Part I of Schedule 1 to this Order, the new authority which is specified in column (2) of that Part in relation to that old authority;
as respects each of the old authorities referred to in Part II of that Schedule, the new authority which is determined, in accordance with that Part, to be the relevant new authority in relation to that old authority.
3
In Schedule 3 to this Order (National Health Service regions) —
a
references in column (3) to the area of a former borough are references to such an area as existing immediately before 1st April 1974; and
b
references in that column to other local government areas are references to such areas as determined under the Local Government Act 1972 on 1st August 1981, and no account shall be taken for the purposes of that Schedule of any subsequent change effected under that Act in the boundaries of those areas.
Determination of regions
2
1
The regions specified in Schedule 2 to this Order are hereby abolished.
2
Each of the regions described in column (3) of Schedule 3 to this Order and numbered 2 and 7 in column (1) of that Schedule shall continue to be determined as a region for the purposes of section 8 of the Act and to be known by the name specified in relation to it in column (2) of that Schedule.
3
Each of the regions described in column (3) of Schedule 3 to this Order and numbered 1, 3, 4, 5, 6 and 8 in column (1) of that Schedule is hereby determined as a region for the purposes of section 8 of the Act and shall be known by the name specified in relation to it in column (2) of that Schedule.
Transfer of officers employed by Regional Health Authorities
3
1
Except as provided by paragraphs (2) and (3) of this article, any officer employed immediately before the material date by any of the old authorities shall on the material date be transferred to the employment of the relevant new authority, and the contract of employment of that officer shall be modified so as to substitute as the employer the relevant new authority.
2
Where —
a
this article makes provision for the transfer of an officer; and
b
the officer in question is employed jointly by any of the old authorities and another person,
that provision shall have effect to transfer that officer to the employment of the relevant new authority and that other person jointly, and the contract of employment of that officer shall be modified so as to substitute the relevant new authority as one of the joint employers.
3
This article shall not apply to any officer whose employment is, on the material date, to be transferred —
a
by or under Part I of the National Health Service and Community Care Act 1990 , to a National Health Service trust; or
b
under the National Health Service (Transfer of Officers) (No.2) Regulations 1986 , to another health authority.
Preservation of training arrangements
4
Training arrangements made by any of the old authorities under which any officer transferred by this Order is undergoing, or is to undergo, a course of training or has entered, or is going to enter, into an apprenticeship, and which have not been discharged before the material date, shall continue to apply with the substitution for the old authority of the relevant new authority.
Enforceability of rights
5
Subject to the following provisions of this Order, any right which was enforceable by or against any of the old authorities shall be enforceable by or against the relevant new authority.
Winding up of affairs of old authorities
6
Each new authority shall take, in accordance with such directions as may be given by the Secretary of State, such action as may be necessary for the winding up of the affairs of any old authority in relation to which it is the relevant new authority.
Accounts of old authorities
7
Any duty imposed on any of the old authorities by section 98 of the Act, but not performed by the material date, shall be performed by the relevant new authority in accordance with the provisions of that section, any regulations made under that section and any directions which may be given by the Secretary of State.
Provision for continuity in exercise of functions
8
1
Anything duly done by, or any application duly made by, or any direction, authorisation or notice duly given to or by, any of the old authorities shall be deemed to have been duly done by, or made by or given to or by the relevant new authority.
2
Any instrument made by any of the old authorities shall continue in force, unless it is expressed to cease to be in force sooner, until it is varied or revoked by the relevant new authority.
3
Any form supplied by any of the old authorities and any form supplied by the Secretary of State relating to any of the old authorities shall continue to be a valid form in relation to the relevant new authority until it is cancelled or withdrawn by the Secretary of State or the relevant new authority, as if any reference contained in such a form to any of the old authorities were a reference to the relevant new authority.
Accommodation and services made available on payment of charges
9
To the extent that any accommodation and services at any hospital managed by any of the old authorities are, immediately before the material date, authorised to be made available under section 65 of the Act, they shall continue to be authorised to be made available under that section, to the extent determined by that old authority, on or after that date until such authorisation is varied or revoked by the relevant new authority.
Investigation of complaints by Health Service Commissioner
10
A complaint made under the Health Service Commissioners Act 1993 to the Health Service Commissioner for England in relation to any of the old authorities, whether made before, on or after the material date, may be investigated by that Commissioner, notwithstanding the abolition of that authority, as if the complaint had been made in relation to the relevant new authority.
Transfer of trust property of old authorities
11
Any trust property vested immediately before the material date in any of the old authorities shall on the material date be transferred to the relevant new authority.
Exercise of powers in relation to trusts
12
Where, immediately before the material date, any power to appoint trustees of a charity connected with purposes relating to the health service is under the trusts of the charity vested in any of the old authorities that power shall vest on the material date in the relevant new authority.
Appointment of new trustees
13
Where, under the trusts of a charity connected with health service purposes, the charity trustees immediately before the material date include a person who is a trustee by virtue of his office with any of the old authorities, the trustees shall from that date instead include the holder of the corresponding office with the relevant new authority.
Revocations
14
The Orders specified in column (1) of Schedule 4 to this Order shall be revoked to the extent specified in column (3) of that Schedule.
Signed by authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State,
Department of Health
10th March 1994


text:
Title and commencement
1
This Scheme may be cited as the Fishing Vessels (Decommissioning) Scheme 1994 and shall come into force on 6th July 1994.
Interpretation
2
1
In this Scheme, unless the context otherwise requires–
“capacity units”, in relation to a vessel, means–
( L × B ) + ( 0.45 × P )
where:
L is the length of the vessel expressed in metres,
B is the breadth of the vessel expressed in metres, and
P is the engine power of the vessel expressed in kilowatts;
“Commission Decision 92/593” means Commission Decision 92/593/ EEC on a multiannual guidance programme for the fishing fleet of United Kingdom for the period 1993 to 1996 pursuant to Council Regulation (EEC) No. 4028/86 ;
“Council Regulation 2930/86” means Council Regulation (EEC) No. 2930/86 defining characteristics for fishing vessels ;
“decommissioning”, in relation to a vessel, means the permanent withdrawal of that vessel from operation within the sea fish industry by means of scrapping and references to “decommissioning grant” shall be construed accordingly;
“fishing trips” includes time spent steaming between port and fishing ground and between one fishing ground and another;
“length”, in relation to a vessel, except in the case of paragraph 3(1)(e), means the length calculated in accordance with the rules specified in Article 2(1) of Council Regulation 2930/86;
“licence” means one or more licences granted in respect of a vessel under section 4 of the Sea Fish (Conservation) Act 1967 ;
“the Ministers” means the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with the sea fish industry in Scotland, Wales and Northern Ireland;
“the register” means the register of fishing vessels established under section 1 of the Merchant Shipping (Registration, etc ) Act 1993 and references to “registered” shall be construed accordingly;
“scrapping”, in relation to a vessel, means permanently breaking up the vessel, or otherwise permanently disabling it (but not, in either case, by scuttling), so that it is incapable of use for any seagoing purpose.
2
Any reference in this Scheme to a numbered paragraph shall, unless the context otherwise requires, be construed as a reference to the paragraph bearing that number in this Scheme.
3
Any payment of grant made under this Scheme by the Ministers may be made by any of them and any reference in the Scheme to such a payment shall be construed accordingly.
Eligibility for decommissioning grant
3
1
Any person who owns a registered fishing vessel —
a
which is over 10 metres in length,
b
in respect of which there is a licence which authorises the fishing throughout Community waters for the following species of fish for which the United Kingdom has a share of the Community total allowable catch : herring ( Clupea harengus), mackerel (Scomber scombrus), saithe (Pollachius virens), anglerfish (Lophiidae), cod (Gadus morhua), haddock (Melanogrammus aeglefinus), whiting (Merlangius merlangus), hake (Merluccius merluccius), plaice (Pleuronectes platessa) and sole (Solea solea),
c
which has spent at least 100 days at sea on fishing trips in Community waters whilst registered as a United Kingdom fishing vessel during each of the calendar years 1992 and 1993,
d
which is at least 10 years old at the date of the application, and
e
which, in the case of a vessel over 12 metres in length had, on the date of application, either a valid fishing vessel certificate under the provisions of the Fishing Vessels (Safety Provisions) Rules 1975 or a letter confirming the completion of a satisfactory survey issued by the Secretary of State for Transport, or, in the case of any other vessel, in the opinion of the Ministers is fit for undertaking sea fishing trips without the need for major repairs or alterations, is eligible to apply for a decommissioning grant.
2
Any person who owns a registered fishing vessel in respect of which an application was approved by the Ministers under the Fishing Vessels (Decommissioning) Scheme 1993 but which was not decommissioned, shall not be eligible to apply for a decommissioning grant in respect of that vessel under this Scheme.
3
For the purposes of subparagraph (1)(c) above–
a
a “day” means all or any part of a period of 24 consecutive hours beginning at midnight,
b
“Community waters” means waters which are under the sovereignty or jurisdiction of a member State.
4
For the purposes of subparagraph (1)(e) above, “length” in relation to a vessel means its registered length.
Application for decommissioning grant
4
1
The Ministers shall publish in such manner as they consider appropriate a notice inviting applications for grant under this Scheme and specifying the closing date for such applications.
2
An application made in pursuance of a notice under subparagraph (1) above shall be in writing in such form and manner and with such information and documentation as the Ministers may require and shall be delivered to such address as they may direct.
3
No more than one application in pursuance of a notice under subparagraph (1) above may be made in respect of a vessel.
4
The foregoing provisions of this paragraph shall apply in respect of any subsequent notices inviting applications for grant under this Scheme.
5
If an application for grant under this Scheme has been approved in respect of a vessel, no further application in respect of that vessel may be made under this Scheme.
5
An application for grant under this Scheme shall include a bid stating the amount of grant for which the applicant offers to scrap the vessel.
Consideration of applications
6
1
As soon as reasonably practicable after the date specified in a notice under paragraph 4(1) as the closing date for applications the Ministers shall–
a
identify those applications made in pursuance of that notice which satisfy the foregoing provisions of this Scheme,
b
divide the bid included in each such application by the number of capacity units of the vessel concerned, and
c
place each such application in rank according to the result of the calculation referred to in subparagraph (b) above.
2
The Ministers may reject any application for grant under this Scheme if they consider the amount of the bid in the application to be unreasonable, having regard to–
a
the extent to which approval of the application would contribute towards the objectives of the United Kingdom’s multiannual guidance programme for its fishing fleet as approved in Commission Decision 92/593;
b
the amount of money allocated for this Scheme.
3
The Ministers shall reject any application for grant under this Scheme if they have reasonable grounds for suspecting that there has been any fixing or adjustment of the amount of a bid by or under or in accordance with any agreement (whether legally binding or not) or arrangement with another person.
4
Subject to subparagraphs (2) and (3) above, the Ministers shall approve applications by proceeding through the rank referred to in subparagraph (1)(c) above from the application incorporating the lowest amount bid per capacity unit towards the application incorporating the highest amount bid per capacity unit until the maximum amount of money allocated for the Scheme is reached.
5
Where as a result of the procedure referred to in subparagraph (4) above there are two or more identical bids per capacity unit which are higher than the amount of any other bid which has been approved, and there is insufficient money to meet all of them, in deciding which bid or bids to accept the Ministers may take into account the amount of time spent at sea on fishing trips in Community waters by each of the vessels concerned during the calendar years 1992 and 1993 with a view to giving preference to vessels that spent more time at sea in those years.
Approval of applications
7
1
The Ministers shall notify each applicant in writing of the result of his application.
2
Applicants whose bids have been approved shall be eligible for payment of grant.
Conditions for payment of grant
8
No grant shall be paid under this Scheme unless the conditions set out in paragraphs 9 to 12 have been complied with.
9
The vessel shall not be scrapped before the applicant has been notified in accordance with paragraph 7(1) and the method has been approved under paragraph 10(3).
10
1
The applicant shall ensure that the vessel is scrapped in a member State.
2
At least two weeks prior to the scrapping of the vessel the applicant shall notify the Ministers in writing of the intended date and place of scrapping and of the proposed method of scrapping.
3
The method of scrapping shall conform to that proposed to, and approved by, the Ministers.
11
1
The applicant shall surrender the licence referred to in paragraph 3(1)(b) above and any other current licence in respect of the vessel to the Ministers.
2
The applicant shall take all necessary steps to ensure that the vessel is removed from the register.
3
The applicant shall furnish to the Ministers before 1st March 1995 a declaration that the vessel has been scrapped, that it has been removed from the register and that the licence in respect of the vessel has been surrendered.
12
The applicant shall take all necessary steps to ensure that any person authorised in writing by the Ministers shall on producing, if required to do so, some duly authenticated document to show his authority, have the right at any reasonable time to inspect the vessel, and the carrying out of its scrapping, for the purpose of establishing that the provisions of this Scheme have been met.
Amount of grant
13
The amount of decommissioning grant in respect of a vessel shall be the amount of the bid made by the applicant in his application.
False statements
14
If any person makes a false statement or furnishes false information in connection with an application for a decommissioning grant under this Scheme, any payment of grant to that applicant may at any time be refused and any such payment already made in relation to that application may be recovered as a civil debt or, in Scotland, as a debt.
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 14th June 1994.
Gillian Shephard
Minister of Agriculture, Fisheries and Food
Hector Monro
Parliamentary Under Secretary of State,
Scottish Office
13th June 1994
Signed by authority of the Secretary of State for Wales.
Gwilym Jones
Parliamentary Under Secretary of State,
Welsh Office
14th June 1994
Patrick Mayhew
Secretary of State for Northern Ireland
15th June 1994
We approve,
Timothy Wood
Irvine Patnick
Two of the Lords Commissioners of Her Majesty’s Treasury
14th June 1994


text:
1
This Order may be cited as the Education (London Residuary Body) (Property Transfer) (Amendment) (No. 2) Order 1994 and shall come into force on 1st January 1995.
2
The Education (London Residuary Body) (Property Transfer) Order 1992 is amended as follows.
3
For article 4(6) the following paragraph is substituted:
The former Henry Thornton Secondary School, 45, Clapham Common South Side, SW4, is transferred subject to the condition that by 1st April 1995 it be brought into use wholly or mainly for the purposes of an institution for the full–time education of persons over compulsory school age who have not attained the age of nineteen years.
4
After article 4(6) the following paragraphs are inserted:
6A
Subject to paragraph (6B) below, the former Shoreditch School and site, Falkirk Street, N1 and the former Shoreditch School Site Extension, 77 Kingsland Street/la Redvers Street, E2, are transferred subject to the condition that by 1st September 1998 they be brought into use wholly or mainly for the purposes of an institution for the education of persons over compulsory school age.
6B
Notwithstanding the condition referred to in paragraph 6A the land and buildings which are the subject of a contract dated 5th December 1994 between Hackney Community College (“the transferor”) and Russell Barrie Gould, Barrie Castell Gould, Sylvia Dorothy Gould and Stuart Castell Gould (“the transferees”) may be transferred by the transferor to the transferees pursuant to that contract free of any duty or requirement imposed by that condition.
5
In article 4(9) after “(6)” there is inserted “(6A),”.
6
In article 4(10) for “(6)” there is substituted “(6A)”.
Gillian Shephard
Secretary of State for Education
6th December 1994


text:
Citation and commencement
1
This Order may be cited as the Rent Officers (Additional Functions) (Amendment No. 2) Order 1994 and shall come into force on 1st January 1995.
Amendments
2
1
The Rent Officers (Additional Functions) Order 1990 is amended in accordance with the following provisions of this article.
2
In article 2(1) for the definition of local authority substitute —
“local authority” has the same meaning as it has in the Social Security Administration Act 1992 in relation to England and in relation to Wales;
.
3
At the end of article 2(2) (notices to be in writing) add “, except in a case where the recipient consents, either generally or specifically, to the notice or application being transmitted by electronic means”.
4
In paragraph 2A of Schedule 1 (exceptionally high rents) —
a
in sub-paragraph (1) for “in the registration area in which the dwelling is situated” substitute —
of dwellings which —
a
are in the same locality as the dwelling (or in as similar a locality as is reasonably practicable), and
b
have the same number of bedrooms and other rooms suitable for living in as the dwelling (or, in a case where the dwelling does not accord with the size criteria for the occupiers, the same number of such bedrooms and other rooms as does so accord)
;
b
in sub-paragraph (2) omit the definition of registration area;
c
for sub-paragraph (3) substitute —
3
If the rent officer determines under sub-paragraph (1) that the rent is exceptionally high, the rent officer shall also determine the highest rent, which is not an exceptionally high rent, which a landlord might reasonably have been expected to obtain at the relevant time (on the assumption that no one who would have been entitled to housing benefit had sought or is seeking the tenancy) for an assured tenancy of a dwelling which —
a
is in the same locality as the dwelling,
b
has the same number of bedrooms or other rooms suitable for living in as the dwelling (or, in a case where the dwelling does not accord with the size criteria for the occupiers, the same number of such bedrooms and other rooms as does so accord), and
c
is in a reasonable state of repair.
; and
d
omit paragraph (4).
Transitional provision
3
The amendments made by this Order do not have effect in a case where an application is made —
a
for a determination before the date this Order comes into force, or
b
for a re-determination where the determination was made before that date.
Signed by authority of the Secretary of State
David Curry
Minister of State,
Department of the Environment
28th November 1994
John Redwood
Secretary of State for Wales
28th November 1994


text:
1
This Order may be cited as the A12 Trunk Road (Lowestoft Eastern Relief Road) (Trunking and Detrunking) Order 1994 and shall come into force on 24th October 1994.
2
In this Order —
a
all measurements of distance are approximate only, and are measured along the route of the relevant highway;
b
i
“the new road” means the new highway which the Suffolk County Council has constructed along the route described in Schedule 1 to this Order;
ii
“the plan” means the plan numbered HA10/2E/355 marked “The A12 Trunk Road (Lowestoft Eastern Relief Road) (Trunking and Detrunking) Order 1994.”, signed by authority of the Secretary of State for Transport and deposited at the Department of Transport, Romney House, 43 Marsham Street, London SW1P 3PY; and
iii
“the trunk road” means the London-Great Yarmouth Trunk Road (A12).
3
From the date when this Order comes into force —
a
the new road shall become a trunk road, and
b
the length of the trunk road described in Schedule 2 to this Order, which is shown by broad black dashes on the plan, shall cease to be a trunk road.
4
The centre line of the new road is indicated by a black band on the plan.
Signed by authority of the Secretary of State for Transport
J. Turner
Government Regional Director, Eastern Region
19th September 1994