type: legislation

jurisdiction: Switzerland

text: 810.306English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Ordinance on Clinical Trials with Medical Devices(ClinO-MD)of 1 July 2020 (Status as of 26 May 2021)The Swiss Federal Council,based on the Human Research Act of 30 September 20111 (HRA)and on Articles 54 paragraphs 3, 6 and 8, 54b paragraphs 2 and 3 and 82 of the Therapeutic Products Act of 15 December 20002 (TPA),ordains:1 SR 810.302 SR 812.21Chapter 1 General Provisions  Section 1 Subject matter, Definitions and Applicable Provisions  Art. 1 Subject matter  1 This Ordinance shall regulate:a. the requirements pertaining to clinical trials with medical devices and other devices in accordance with Article 1 of the Medical Devices Ordinance of 1 July 2020 (MedDO)3;b. the approval and reporting procedures for clinical trials involving the devices in accordance with letter a;c. the duties and responsibilities of research ethics committees (Ethics Committees), the Swiss Agency for Therapeutic Products (Swissmedic) and the Federal Office of Public Health (FOPH) in connection with the approval and reporting procedures;d. the registration of clinical trials involving devices in accordance with letter a;e. public access to information concerning clinical trials.2 In this Ordinance, the term devices is used to designate all products defined in paragraph 1 letter a.3 SR 812.213Art. 2 Definitions  The following definitions shall apply in this Ordinance:a. clinical trial means the systematic investigation of a device involving one or more persons for the purpose of assessing the safety or performance of the device;b. conformity-related clinical trial means a clinical trial conducted to demonstrate the conformity of the device being investigated;c. contracting state means any state that is bound to mutually recognise conformity assessments and conformity procedures for devices by an agreement with Switzerland under international law based on equivalent legislation;d. sponsor means any individual or institution or organisation that takes responsibility for the initiation of a clinical trial – specifically its instigation, management and financing – in Switzerland;e. investigator means any individual responsible for the conduct of a clinical trial and for the protection of the participants at a clinical trial site; any participant who assumes responsibility for initiating a clinical trial in Switzerland is simultaneously the trial’s sponsor.Art. 3 Applicable provisions  1 The following provisions of the Ordinance of 20 September 20134 on Clinical Trials in Human Research (ClinO) apply to clinical trials with devices:a. for scientific integrity and scientific quality: Articles 3 and 4 ClinO;b. for participant information, consent and withdrawal of consent: Articles 7–9 ClinO;c. for liability and indemnification: Article 10 paragraphs 1 letter c and 2 and Article 11–14 ClinO;d. for the conduct of clinical trials in emergency situations: Articles 15–17 ClinO;e. for the storage of personal health data and biological material: Article 18 ClinO;f. for inspections and administrative measures: Article 46 paragraphs 1, 2, 4 and 5 and Article 47 and 48 ClinO.2 The powers exercised by Swissmedic and the duty to cooperate and provide information incumbent on the sponsor and investigator in the event of inspections and administrative measures are governed mutatis mutandis by Articles 77 and 78 MedDO5.3 Clinical trials with in vitro diagnostic devices, devices as specified in Art. 2a paragraph 2 TPA or combinations as specified in Article 2 paragraph 1 letters f and g MedDO are subject to ClinO.64 SR 810.3055 SR 812.2136 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Section 2  General Obligations of the Sponsor and Investigator and Professional Qualifications Art. 4 General obligations of the sponsor and investigator  1 The sponsor and investigator must conduct clinical trials in accordance with Article 72 and Chapters I and III of Annex XV to Regulation (EU) 2017/7457 on medical devices (EU-MDR).2 Compliance with the requirements of paragraph 1, specified in greater detail by designated technical standards8 or common specifications in accordance with Article 9 paragraph 1 EU-MDR, is presumed if the clinical trial is conducted in accordance with those standards or specifications. Article 6 paragraph 5 MedDO9 applies mutatis mutandis.3 If the sponsor is not domiciled in Switzerland and does not have a place of business there, it must designate an agent that is domiciled or has a place of business in Switzerland as an address for correspondence. This agent must ensure compliance with the sponsor’s obligations.7 Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117 of 5.5. 2017, p. 1; last amended by Regulation (EU) 2002/561, OJ L 130 of 24.4.2020, p. 18.8  The electrical standards can be obtained from the industry association Electrosuisse, Luppmenstrasse 1, 8320 Fehraltorf, www.electrosuisse.ch, and the other standards from the Swiss Association for Standardization (SNV), Sulzerallee 70, 8404 Winterthur, www.snv.ch9 SR 812.213Art. 5 Professional qualifications  1 Clinical trial investigators must:a. be entitled to practise independently as a doctor or in another profession that specifically qualifies them to conduct the clinical trial;b. demonstrate adequate knowledge of the internationally recognised requirements for the conduct of clinical trials and the specialist knowledge and experience required for the clinical trial; andc. possess knowledge of the legal requirements governing clinical trials or be able to guarantee the availability of such knowledge by recruiting appropriate expertise.2 The remaining people conducting the clinical trial must possess the training or experience in the specialist field that is required to conduct clinical trials.Chapter 2 Approval and Reporting Procedures  Section 1 General Provisions  Art. 6 Categorisation of clinical trials  1 Clinical trials fall into category A if: a. the device to be investigated carries a conformity marking in accordance with Article 13 MedDO10; b. the device to be investigated is used in accordance with the instructions for use; andc. it is not prohibited to make the device to be investigated available on the market, put it into service or use it in Switzerland.2 Category A clinical trials are divided into sub-categories as follows:a. if the participants do not undergo additional invasive or stressful procedures compared with the procedures applied when the device is used under normal conditions: sub-category A1;b. if the participants undergo additional invasive or stressful procedures compared with the procedures applied when the device is used under normal conditions: sub-category A2.3 Clinical trials fall into category C if:a. the device carries a conformity marking in accordance with Article 13 MedDO but is not used in accordance with the instructions for use (sub-category C1);b. the device does not carry a conformity marking in accordance with Article 13 MedDO (sub-category C2); orc. it is prohibited to make the device available on the market, put it into service or use it in Switzerland (sub-category C3).10 SR 812.213Art. 7 Exemption from mandatory approval  Category A clinical trials are exempt from the requirement to obtain approval from Swissmedic set out in Article 54 paragraph 1 TPA.Art. 8 Data processing in electronic systems and information sharing  1–5 ...116 The medical devices information system in accordance with Article 62c TPA and the information system operated by the Cantons in accordance with Article 56a HRA may contain information on administrative or criminal proceedings or sanctions concerning the sponsor, investigator or manufacturer that Swissmedic and the competent Ethics Committee require in order to fulfil their duties under this Ordinance.7 Swissmedic shall, upon request, forward the highly sensitive data in accordance with paragraph 6 to the Ethics Committees.11 To come into force in due course (Art. 50 para. 2).Art. 9 Information and coordination for approval procedures  The competent Ethics Committee and Swissmedic shall provide information to each other on the following aspects and coordinate their assessments:a. categorisation of the clinical trial in accordance with Article 6;b. aspects concerning the review areas in accordance with Article 11 and Article 17;c. the conduct of the procedures set out in Articles 12 and 19 and in Chapter 3.Section 2 Procedures to be performed by the Competent Ethics Committee Art. 10 Application  1 The sponsor shall submit the application documents specified in Annex 1.122 The Ethics Committee may demand additional information.3 The investigator may submit the application in place of the sponsor. In this case, it assumes the duties of the sponsor as set out in Articles 14 and 15 and the duty to notify and report to the competent Ethics Committee. The sponsor must co-sign the application documents.12 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Art. 11 Review areas  The areas to be reviewed by the Ethics Committee are governed by Article 25 ClinO13.13 SR 810.305Art. 12 Procedures and time limits  1 The Ethics Committee shall confirm receipt of the application to the sponsor within 10 days and notify the sponsor of any formal shortcomings in the application documents. It shall give the applicant 10 days to rectify the shortcomings and inform the applicant that it will not admit the application if the shortcomings are not rectified within the deadline.2 It shall make its decision within 40 days of confirming receipt of the formally correct application documents. 3 If the Ethics Committee demands additional information in accordance with Article 10 paragraph 2, the 40-day period shall be paused until the information is received.Art. 13 Multi-centre clinical trials  1 The sponsor shall submit its application for a multi-centre clinical trial in accordance with Article 47 paragraph 2 HRA to the Ethics Committee responsible for the coordinating investigator. The coordinating investigator may submit the application in place of the sponsor. Article 10 paragraph 3 applies mutatis mutandis.2 The coordinating investigator is the person with responsibility in Switzerland for coordinating the investigators responsible for the various trial sites.3 The Lead Committee shall confirm receipt of the application to the sponsor within 10 days and notify it of any formal shortcomings in the application documents. It shall give the applicant 10 days to rectify the shortcomings and inform the applicant that it will not admit the application if the shortcomings are not rectified within the deadline. Upon application, the Lead Committee may extend these deadlines by a period of five days in each case.4 It shall notify the Ethics Committees responsible for the trial sites (participating Ethics Committees) that it has received the application. These shall review the local conditions and notify the Lead Committee of their evaluation within 15 days.5 The Lead Committee shall make its decision within 40 days of confirming receipt of the formally correct application documents.Art. 14 Procedure for investigations involving radiation sources  1 For investigations involving radiation sources, the sponsor shall submit the additional application documents specified in Annex 1 number 4. The approval procedure shall be governed by Articles 10–13 and 15, subject to the paragraphs below.142 The sponsor shall submit the additional application documents specified in Annex 1 number 5 if the effective dose, taking account of the uncertainty factor, exceeds 5mSv per person and year and:15a. the trial involves a radiopharmaceutical that is not authorised in Switzerland;b. the trial involves a radiopharmaceutical that is authorised in Switzerland but does not involve a routine nuclear medical investigation; orc. the trial involves a different radioactive source.3 The Ethics Committee shall forward the application documents to the FOPH in accordance with Annex 1 number 5.4 The FOPH shall send the Ethics Committee its comments on compliance with radiological protection legislation and on the estimated dose. It may grant exemptions to the reporting obligation in accordance with Article 39 paragraph 5.5 The Ethics Committee shall approve the trial if:a. the requirements set out in Article 11 are fulfilled; andb. the FOPH has not submitted any objections to the clinical trial within a reasonable period.6 It shall notify the FOPH of its decision.14 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).15 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Art. 15 Amendments  1 All amendments to an approved clinical trial that could have a significant impact on the safety, health or rights of participants and on the robustness or reliability of the clinical data obtained (substantial amendments) must be approved by the Ethics Committee prior to their adoption. This obligation does not extend to measures that have to be taken immediately to protect trial participants.2 The sponsor shall submit any application documents specified in Article 10 paragraph 1 that are affected by the amendment. Amendments must be clearly marked. The sponsor shall submit information on the nature of and reasons for the amendment at the same time.3 The Ethics Committee shall issue its decision on substantial amendments within 30 days. Article 12 applies mutatis mutandis. 4 Where a further clinical trial site is to be added and that site lies outside the competence of the Ethics Committee that approved the clinical trial, the procedure set out in Article 13 applies mutatis mutandis.5 Other amendments must be reported to the Ethics Committee with the annual safety report as specified in Article 35.6 For clinical trials in sub-category A2, the sponsor shall also notify the contracting states in which the clinical trial is being conducted or is due to be conducted of the nature of and reasons for the amendments; it shall attach the documents as specified in Annex 1 which are affected by the amendments.Section 3 Approval Procedures to be performed by Swissmedic Art. 16 Application  1 The sponsor shall submit the application documents specified in Annex 1 number 2.2 Swissmedic may demand additional information.3 If the sponsor withdraws its application for conformity-related clinical trials in sub-categories C1 and C2 before Swissmedic has made a decision, it shall inform the contracting states in which the clinical trial is being conducted or is due to be conducted.Art. 17 Review areas  1 For clinical trials, Swissmedic shall verify:a. whether the application is complete;b. whether the requirements of Article 54 paragraph 4 letter b TPA are fulfilled.2 It shall conduct a simplified review if the sponsor demonstrates the following in its application:a. the clinical trial falls into sub-category C1 or C2 and involves a non-invasive device classified as class I or IIa under Article 15 MedDO16;b. use of the device to be investigated entails at most minimal risk for the trial participants;c. the investigator has signed a written agreement with the sponsor requiring the investigator to notify the sponsor without delay of serious adverse events or any other incident as specified in Article 32;d. the sponsor operates a risk management and safety monitoring system.3 Swissmedic shall restrict its simplified review to determining whether the application is complete and the evidence required under paragraph 2 has been provided.16 SR 812.213Art. 18 Clinical trials with devices capable of emitting ionising radiation  1 The additional application documents specified in Annex 1 numbers 4 and 5 must be submitted for category C clinical trials.172 Swissmedic shall invite the FOPH to submit its comments before it approves trials. The FOPH shall review compliance with radiological protection legislation and the estimated dose.3 Swissmedic shall approve the trial if:a. the requirements set out in Article 17 are fulfilled; andb. the FOPH has not submitted any objections to the clinical trial within an appropriate period.4 It shall notify the FOPH of its decision.17 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Art. 19 Procedures and time limits  1 Swissmedic shall confirm receipt of the application to the sponsor within 10 days and notify it of any formal shortcomings in the application documents. It shall give the applicant 10 days to rectify the shortcomings and inform the applicant that it will not admit the application if the shortcomings are not rectified within the deadline. Upon application, Swissmedic may extend the deadline for rectifying the shortcomings by 20 days.2 It shall make its decision within 45 days of confirming receipt of the formally correct application documents. It may only approve a clinical trial if the competent Ethics Committee has approved it beforehand.3 Swissmedic shall also inform the contracting states if it rejects the application.4 If a device is being used in humans for the first time or manufactured using a new process, Swissmedic may extend the period specified in paragraph 2 by no more than 20 days. It shall notify the sponsor of the extension.5 If Swissmedic demands additional information as specified in Article 16 paragraph 2, the 45-day period shall be paused until the information is received.Art. 20 Amendments  1 Substantial amendments to an approved clinical trial, in accordance with Article 15 paragraph 1, must be submitted to Swissmedic for approval prior to their adoption. This obligation does not extend to measures that have to be taken immediately to protect trial participants. 2 The sponsor shall submit to Swissmedic the application documents as specified in Article 16 paragraph 1 that are affected by the amendment. It shall submit information on the nature of and reasons for the amendment at the same time.3 Swissmedic shall make its decision within 38 days of receiving all the application documents affected by the amendment. Article 19 applies mutatis mutandis. This period may be extended by seven days.4 Other amendments applicable to the application documents submitted to Swissmedic must be notified to Swissmedic as quickly as possible.4bis For conformity-related clinical trials in sub-categories C1 and C2 that are also being conducted or are also due to be conducted in EU or EEA states, the sponsor shall notify Swissmedic of the nature of and reasons for substantial amendments to the clinical trial in EU or EEA states that affect the protocol, investigational device or instructions for use for the investigational device.185 The sponsor of a conformity-related clinical trial in sub-categories C1 and C2 shall also notify the contracting states in which the clinical trial is being conducted or is due to be conducted of the nature of and reasons for the amendments; it shall attach the documents as specified in Annex 1 which are affected by the amendments.18 Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Chapter 3 Coordinated Assessment Procedure  Art. 21–3119 19 To come into force in due course (Art. 50 para. 2).Chapter 4 Documentation, Notifications and Reporting  Section 1  Documentation and Reporting of Incidents and of Safety and Protection Measures Art. 32 Documentation of adverse events  1 The sponsor must document the following adverse events that occur during a clinical trial in a standardised form:a. adverse events of all types designated in the protocol as crucial to assessing the results of the clinical trial;b. all serious adverse events:c. any device deficiency that could have resulted in serious adverse events under less propitious circumstances or if appropriate action or an intervention had not taken place;d. all new findings relating to a documented incident as specified in letters a–c. 2 The sponsor shall provide Swissmedic and the competent Ethics Committee with the documentation specified in paragraph 1 upon request.3 The definitions of adverse events and device deficiencies are those in Article 2 numbers 57–59 EU-MDR20.20  See the footnote to Art. 4 para. 1.Art. 33 Reporting of serious adverse events21  1 For category C clinical trials, the sponsor shall notify Swissmedic and the competent Ethics Committee without delay of:a. each serious adverse event that has a causal relationship with the investigational device, the comparator device or a test procedure or where a causal relationship appears entirely possible;b. any device deficiency that could have resulted in serious adverse events under less propitious circumstances or if appropriate action or an intervention had not taken place;c. all new findings relating to a reported incident as specified in letters a and b.1bis For conformity-related clinical trials in sub-categories C1 and C2 that are also being conducted abroad, the sponsor shall also notify Swissmedic and the competent Ethics Committee without delay of all incidents, device deficiencies and findings as specified in paragraph 1 which arise from the conduct of the clinical trial abroad.222 To ensure reporting is not delayed, the sponsor may provisionally submit an incomplete report. 3 For conformity-related clinical trials in sub-categories C1 and C2, the sponsor shall also provide reports in accordance with paragraph 1 to those contracting states in which the clinical trial is being conducted or is due to be conducted4 For category A clinical trials, the sponsor shall report:a. to the competent Ethics Committee: without delay any serious adverse event for which a causal relationship between the event and the test procedure used in the clinical trial has been ascertained; paragraph 2 is applicable;b. to Swissmedic and the competent Ethics Committee: the reports as specified in Articles 87–90 EU-MDR23.21 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).22 Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).23  See the footnote to Art. 4 para. 1.Art. 34 Reporting of safety and protective measures  1 If safety and protective measures have to be implemented without delay during the course of a clinical trial, the sponsor shall report these measures and the circumstances that necessitated them to the Ethics Committee within two days.1bis For clinical trials that are also being conducted or are also due to be conducted in EU or EEA states, the sponsor shall also notify the Ethics Committee within two days of all prescribed or voluntary safety and protective measures that are being implemented in EU or EEA states and the circumstances that necessitated them.242 The sponsor must report any clinical trial that is terminated or interrupted for reasons of safety in accordance with Article 36 paragraph 4.3 For category C clinical trials, reporting under paragraphs 1 and 1bis must also be submitted to Swissmedic.254 For conformity-related clinical trials in sub-categories C1 and C2, the sponsor shall also provide reports under paragraph 1 to the contracting states in which the clinical trial is being conducted or is due to be conducted24 Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).25 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Section 2  Reporting on the Safety of Participants and Reporting at the Conclusion, Termination or Interruption of a Clinical Trial Art. 35 Annual reporting on the safety of participants  1 Once a year, the sponsor shall submit to the competent Ethics Committee a list of the serious adverse events and device deficiencies in accordance with Article 33 and provide it with a report on their severity, causal relationship with the device and the intervention, as well as on the safety of the participants (Annual Safety Report, ASR).2 For category C clinical trials that are also being conducted abroad, the list and report must also include adverse events and device deficiencies that occurred abroad.2bis For category C clinical trials that are also being conducted in, or are also due to be conducted in, EU or EEA states, the report in accordance with paragraph 2 must include the status of the clinical trial in the states in question.2626 Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Art. 36 Reporting the conclusion, termination and interruption of a clinical trial  1 The sponsor shall report the conclusion of the clinical trial in Switzerland to the Ethics Committee within 15 days.2 Unless otherwise specified in the protocol, the conclusion of the clinical trial is deemed to be the final visit by the final participant.3 The sponsor shall report the termination or interruption of the clinical trial to the Ethics Committee within 15 days. The report must set out the reasons for the termination or interruption.4 If the trial is terminated or interrupted for reasons of safety, the following shall apply:a. The report must be submitted within 24 hours.b. The report must also be submitted to those contracting states in which the clinical trial is being conducted or is due to be conducted.4bis For clinical trials that are also being conducted in EU or EEA states, the sponsor must also report any termination or interruption of the trial in EU or EEA states to the Ethics Committee within 24 hours if the termination or interruption was for reasons of safety.275 If a multi-centre clinical trial is terminated or interrupted at one of the trial sites, the sponsor must also perform the reporting according to paragraph 3 and 4 to the other participating Ethics Committees.27 Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Art. 37 Final report  1 The sponsor shall submit to the Ethics Committee a final report in accordance with Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV to EU-MDR28:a. within one year of the clinical trial being concluded;b. within three months of the clinical trial being terminated or interrupted.2 If scientific reasons prevent compliance with the reporting deadline specified in paragraph 1 letter a, the sponsor must submit the report as soon as it is available. The protocol must specify when the final report will be submitted and provide reasons.3 A summary in lay language must be included with the final report.28  See the footnote to Art. 4 para. 1.Art. 38 Notification and reporting to Swissmedic  For category C clinical trials, the notifications and reports specified in Articles 35–37 must also be submitted to Swissmedic.Section 3  Reporting in connection with the Use of Radiation Sources and Document Retention Art. 39 Verification, notification and reporting in connection with the use of radiation sources  1 For clinical trials with devices capable of emitting ionising radiation and investigations with radiation sources, the sponsor shall verify compliance with the dose constraint specified in Article 45 RPO29.2 Should the dose constraint be exceeded at any time, the sponsor shall notify the fact to the competent Ethics Committee within 7 days of becoming aware of it.3 For category C trials with devices that emit ionising radiation, the notification in accordance with paragraph 2 must also be sent to Swissmedic.4 The competent Ethics Committee and Swissmedic may consult the FOPH for expert advice on assessing the calculated or estimated dose and on determining further measures.5 For clinical trials in accordance with paragraph 1, the sponsor shall document in the final report all relevant radiological protection information, particularly an estimation of the dose the participants were exposed to; this shall not apply in the case of an exemption from the reporting obligation as specified in Article 14 paragraph 4.6 The competent Ethics Committee shall forward the final report to the FOPH.29 SR 814.501Art. 40 Document retention requirements  1 The sponsor must retain all data concerning the clinical trial until the expiry date of the last series of devices used in the trial, but for a minimum of ten years following the conclusion or termination of the clinical trial. The retention period for implantable devices is at least 15 years.2 The investigator must retain all documents required to identify and provide post-trial care to participants, as well as all other original data, for at least ten years after the conclusion or termination of the clinical trial. The retention period for implantable devices is at least 15 years.Chapter 5 Transparency Art. 41 and 4230 30 To come into force in due course (Art. 50 para. 2).Chapter 6 Final Provisions Art. 43 Updating of the annexes  The Federal Department of Home Affairs may update Annex 1 in line with international or technical developments. Where updates may pose technical barriers to trade, it shall effect such updates by mutual agreement with the Federal Department of Economic Affairs, Education and Research.Art. 44 Amendment of other legislation  The amendment of other legislation is regulated in Annex 2.Art. 45 Information on directly applicable legal acts of the European Commission  Swissmedic shall provide on its website information on legal acts of the European Commission that, under the terms of this Ordinance, are directly applicable in Switzerland in the version binding upon the Member States of the European Union.Art. 46 Harmonisation of enforcement  1 Swissmedic and the Ethics Committees may prescribe electronic forms and technical procedures for inputting and transmitting documents and for sharing information in the electronic systems in accordance with Article 8.2 For the purposes of enforcing this Ordinance, particularly the provision of electronic forms and aids to enforcement, Swissmedic and the Ethics Committees shall comply with the implementing acts adopted by the European Commission under Articles 70, 78 and 81 EU-MDR31, specifically in reference to:a. harmonised electronic forms for applications for clinical trials and their assessment, procedures to be performed by Ethics Committees and Swissmedic and for the coordinated assessment procedure;b. harmonised electronic forms for substantial amendments;c. harmonised electronic forms for reporting serious adverse events and device deficiencies;d. the exchange of information between the Member States and Switzerland in the course of communication of intended measures, the termination of a clinical trial for reasons of safety, the withdrawal of an application and refusal to authorise a clinical trial;e. time limits for reporting serious adverse events and device deficiencies that are notifiable by virtue of their gravity;f. the requirements of Chapter II of Annex XV to EU-MDR;g. the coordinated assessment procedure.31  See the footnote to Art. 4 para. 1.Art. 47 Cooperation with the European Commission and authorities of the contracting states  1 Where provided for by international agreements, Swissmedic shall cooperate with the European Commission and the authorities of the contracting states.2 In doing so, Swissmedic shall involve the Ethics Committees in appropriate fashion where their area of responsibility is affected.Art. 48 Transitional provisions for clinical trials approved under previous legislation and involving medical devices  1 Approvals for clinical trials of devices issued by the competent Ethics Committee and Swissmedic prior to the entry into force of this Ordinance shall remain valid until their expiry date.2 The results of clinical trials of devices that are still in progress when this Ordinance enters into force have to be published in a recognised register in accordance with Article 64 paragraph 1 ClinO32 within the time limit specified in Article 42.3 Where clinical trials in accordance with paragraph 1 undergo substantial amendments, the sponsor must apply for categorisation under Article 6 at the same time.32 SR 810.305Art. 49 Transitional provisions  1 Until Article 8 paragraphs 1, 4 and 5 of this Ordinance comes into force (Art. 50 para. 2), sponsors shall use the following information systems to input and transmit applications, notifications, reports and other information required under this Ordinance:a. the Cantons’ information system in accordance with Article 56a HRA for documents and information intended for the competent Ethics Committee;b. the medical devices information system in accordance with Article 62c TPA for documents and information intended for Swissmedic.2 Until Article 8 paragraphs 2 and 3 of this Ordinance comes into force (Art. 50 para. 2):a. Swissmedic shall use the medical devices information system in accordance with Article 62c TPA to input and transmit decisions and to exchange information with applicants;b. the competent Ethics Committee shall use the Cantons’ information system in accordance with Article 56a HRA for the purposes described in letter a.3 Until Articles 41 and 42 of this Ordinance come into force (Art. 50 para. 2), sponsors must register clinical trials in accordance with Articles 64, 65 paragraphs 1 and 3 and 66 and 67 ClinO33. They must also publish the results of such clinical trials in a recognised register in accordance with Article 64 paragraph 1 ClinO within the following time limits:a.34 for concluded category C clinical trials: at the latest before the device is placed on the market or one year after submitting the final report in accordance with Article 37 if the device has not been placed on the market by this point in time;b. for concluded category A clinical trials and if a trial is terminated or interrupted: immediately after submitting the final report in accordance with Article 37.33 SR 810.30534 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).Art. 50 Commencement  1 Subject to the exceptions in paragraph 2, this Ordinance comes into force on 26 May 2021.2 Articles 8 paragraph 1–5, 21–31, 41 and 42 come into force at a later date.Annex 135 35 Revised by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).(Art. 10 para. 1, 14, 15 para. 6, 16 para. 1, 18 para. 1, 20 para. 5, 23 para. 2)Application documents for the approval procedure for clinical trials 1 Application documents for category A clinical trials  1.1 The application documents specified in Chapter II of Annex XV to EU-MDR36, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts on the basis of Article 70 EU-MDR, must be submitted with the following specification:a. with reference to Chapter II Sections 1.1 and 3.1.2 of Annex XV to EU-MDR (Identification of the sponsor): name, address and contact details of the sponsor and, where the sponsor is not domiciled in Switzerland and does not have a place of business there, its agent in Switzerland;b. the following information in addition to that required by Chapter II Section 3.1 of Annex XV to EU-MDR for multi-centre clinical trials in Switzerland: name, address and contact details of the coordinating investigator in Switzerland.1.1bis For clinical trials that are also being conducted or are also due to be conducted in EU or EEA states, any opinions of the relevant foreign Ethics Committee on the clinical trial must be submitted, including any conditions and the reasons for these conditions.1.2 The following information specified in Chapter II of Annex XV to EU-MDR does not have to be submitted:a. the information in section 1.16;b. the information in sections 2.3–2.8;c. the information in section 4.2.1.3 Swissmedic shall provide on its website information on the delegated acts under section 1.1 that, under the terms of this Ordinance, are directly applicable in Switzerland in the version binding upon the Member States of the EU (Art. 45).36  See the footnote to Art. 4 para. 1.2 Application documents for category C clinical trials  2.1 The application documents specified in Chapter II of Annex XV to EU-MDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts on the basis of Article 70 EU-MDR, must be submitted with the following specifications for Sections 1.1 and 3.1.2 (Identification of the sponsor): name, address and contact details of the sponsor and, if the sponsor is not domiciled in Switzerland and does not have a place of business there, its agent in Switzerland.2.1bis For clinical trials that are also being conducted or are also due to be conducted in EU or EEA states, any decisions or opinions of the relevant foreign medical devices supervisory authority and Ethics Committee on the clinical trial must be submitted, including any conditions and the reasons for these conditions.2.2 If the clinical trial is a multi-centre trial in Switzerland, the name, address and contact details of the coordinating investigator in Switzerland must be provided in addition to the information required under Chapter II Section 3.1.3 of Annex XV to EU-MDR.2.3 The following information specified in Chapter II of Annex XV to EU-MDR does not have to be submitted:a. the information in section 1.16;b. the information in section 4.2.2.4 Swissmedic shall provide on its website information on the delegated acts under section 2.1 that, under the terms of this Ordinance, are directly applicable in Switzerland in the version binding upon the Member States of the EU (Art. 45).3 Application documents for clinical trials in sub-categories C1 and C2 in the coordinated procedure  3.1 General partFor the general part, the application documents specified in Chapter II of Annex XV to EU-MDR, with the exception of the national part in accordance with Article 23 paragraph 2, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts on the basis of Article 70 EU-MDR, must be submitted with the following specifications for Sections 1.1 and 3.1.2 (Identification of the sponsor): name, address and contact details of the sponsor and, where the sponsor is not domiciled in Switzerland, its agent in Switzerland.3.2 National partFor the national part, the application documents specified in Chapter II Sections 1.13, 3.1.3 and 4.2–4.4 of Annex XV to EU-MDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts on the basis of Article 70 EU-MDR, must be submitted with the following specification for Section 3.1.2: For multi-centre trials in Switzerland: name, address and contact details of the coordinating investigator in Switzerland.3.3 Swissmedic shall provide on its website information on the delegated acts under section 3.1 and 3.2 that, under the terms of this Ordinance, are directly applicable in Switzerland in the version binding upon the Member States of the EU (Art. 45).4 Additional application documents for clinical trials with devices capable of emitting ionising radiation and for investigations involving radiation sources (Art. 14 para. 1)  For clinical trials with devices capable of emitting ionising radiation and for investigations involving radiation sources (Art. 14 para. 1), the following additional information and documents must be submitted:a. information on significant radiation protection aspects, particularly a calculation or estimation of the effective dose-equivalent, the doses absorbed by the organs and, if applicable, the doses absorbed by the tumours;b. the necessary permits in accordance with Article 28 of the Radiological Protection Act of 22 March 199137.37 SR 814.505 Additional application documents for category C clinical trials with devices capable of emitting ionising radiation and for clinical trials involving investigations with radiation sources and requiring the comments of the FOPH in accordance with Article 14 paragraph 2  For category C clinical trials with devices capable of emitting ionising radiation (Art. 18) and investigations involving radiation sources that require the comments of the FOPH in accordance with Article 14 paragraph 2, the following information must be submitted in addition to the information listed under number 4:a. if applicable, information on the properties, specifically the pharmacokinetics, quality, stability, radiochemical purity and radionuclide purity;b. for authorised radiopharmaceuticals: the information for healthcare professionals;c. for non-authorised radiopharmaceuticals: information on the manufacturing process and quality control of the radiopharmaceutical, the names of the people responsible for both and their professional qualifications;d. the names of the people responsible for the use of the radiopharmaceutical on humans and their professional qualifications;e. information required by the FOPH form for clinical trials with radiopharmaceuticals or radiolabelled substances38.38 This form can be obtained from FOPH, Radiation Protection Division, 3003 Bern or on the Internet at www.bag.admin.ch > Healthy living > Environment & health > Radiation, radioactivity & sound.Annex 2 (Art. 44)Amendments to other legislation The following are amended as follows:...3939 The amendments can be consulted at AS 2020 3033.


text: 810.308 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Ordinance on Organisational Aspectsof the Human Research Act(HRA Organisation Ordinance, OrgO-HRA)of 20 September 2013 (Status as of 26 May 2021)The Swiss Federal Council,on the basis of Articles 49 paragraphs 1 and 2, 53 paragraph 3, 59 paragraph 6, 60 paragraph 2 and 65 of the Human Research Act of 30 September 20111 (HRA),ordains:1 SR 810.30Chapter 1 Research Ethics Committee  Art. 1 Composition  1 The research ethics committee (ethics committee) shall be composed at least of persons possessing expertise in the following disciplines:a. medicine;b. psychology;c. nursing;d. pharmaceutics or pharmaceutical medicine;e. biology;f. biostatistics;g. ethics; andh. law, including data protection.2 It shall be of balanced composition as regards gender and professional groups.3 The ethics committee must be able to draw on knowledge of local conditions in the various areas of responsibility.4 If the ethics committee lacks the expertise required for the assessment of a research project, it must call in external specialists.Art. 2 Requirements for members  1 Members of the ethics committee must, on commencing their service, attend a course on the duties of the ethics committee and the fundamentals of the assessment of research projects, and must regularly undergo further training in this area.2 The members specified in Article 1 paragraph 1 letters a–c must have experience in the conduct of research projects.Art. 3 Scientific secretariat  1 Persons working for the scientific secretariat must have:a. a degree in medicine, pharmaceutics, natural sciences, psychology or law;b. adequate training in Good Clinical Practice;c. a knowledge of scientific methods for human research projects; andd. a knowledge of the legal requirements governing human research.2 The scientific secretariat shall be staffed at a level that is sufficient:a. to ensure its availability for the committee and for applicants; andb. to guarantee that procedural deadlines are met.Art. 4 Withdrawal from participation  1 Members of the ethics committee shall withdraw from participation in cases where:a. they are personally involved, or otherwise have a personal interest, in the research project;b. persons reporting to them, to whom they report, or with whom they have close personal ties, are involved in the research project; orc. they are an interested party for other reasons.2 Members who are interested parties must not participate in deliberations or in decision-making on the matter in question.Art. 5 Regular procedure  1 The ethics committee shall make decisions under the regular procedure with the participation of at least seven members. The composition of this group shall be such as to guarantee an expert and interdisciplinary assessment of the application.2 Decisions shall be taken after oral deliberations. In justified exceptional cases, it is permissible for proceedings to be conducted in writing; a member may at any time request oral deliberations.3 Decisions of the ethics committee shall be made by majority vote. In the event of a tie, the chair or vice-chair shall have a casting vote.4 The provisions of Articles 6 and 7 are reserved.Art. 6 Simplified procedure  1 The ethics committee shall make decisions with the participation of three members on:a.2 Category A clinical trials, as specified in Article 19 paragraph 1, Article 20 paragraph 1, Article 49 paragraph 1 and Article 61 paragraph 1 of the Ordinance of 20 September 20133 on Clinical Trials (ClinO), provided that the trial does not raise any particular ethical, scientific or legal issues;abis.4 clinical trials of devices in Subcategory A1 as referred to in Article 6 paragraph 1 of the Ordinance of 1 July 20205 on Clinical Trials with Medical Devices, provided the trial does not raise any particular specific ethical, scientific or legal issues;b. Category A research projects involving persons, as specified in Article 7 paragraph 1 of the Human Research Ordinance of 20 September 20136;c. the further use for research of biological material or health-related personal data in the absence of informed consent, in accordance with Article 34 HRA, provided that this does not raise any particular ethical, scientific or legal issues;d. research projects involving deceased persons, with the exception of research projects involving deceased persons undergoing artificial respiration, as specified in Article 37 paragraph 2 HRA;e. significant changes to authorised research projects, if they raise particular ethical, scientific or legal issues.2 The group of three must comprise members from different disciplines specified in Article 1.73 The conduct of proceedings in writing is permissible if no members request oral deliberations.4 The regular procedure shall be adopted if:a. unanimous agreement is not reached; orb. a request to this effect is made by a member of the group of three.2 Amended by Annex No 3 of the O of 19 May 2021, in force since 26 May 2021  (AS 2021 281).3 SR 810.3054 Inserted by Annex 2 No 3 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).5 SR 812.213.36 SR 810.3017 Amended by Annex 2 No 3 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).Art. 7 Decisions to be made by the chair  1 The chair or vice-chair of the ethics committee shall make decisions on:a. research projects involving existing biological material or existing health-related personal data, with the exception of further use in accordance with Article 34 HRA;b. significant changes to authorised research projects which do not raise any particular ethical, scientific or legal issues;c. whether the requirements concerning local conditions in multicentre research projects are met;d. refusal to consider incomplete applications;e. the cancellation of applications which are no longer relevant or have been withdrawn;f. the fulfilment of conditions imposed;g. the ordering of official measures as specified in Article 48 HRA.2 He or she may at any time order the adoption of the simplified or regular procedure.Art. 8 Obligation to retain documents and right of inspection  1 Application documents submitted to the ethics committee, minutes of meetings and correspondence must be retained for ten years after the completion or discontinuation of a research project.2 The cantonal supervisory authority may inspect these documents.Art. 9 Notification requirements  The cantonal supervisory authority shall notify the coordination office as specified in Article 10 of the responsible ethics committee.Chapter 2 Coordination Office  Art. 10 1 The Federal Office of Public Health (FOPH) shall manage the coordination office as specified in Article 55 HRA.2 In particular, the coordination office has the following duties:a. It ensures regular exchanges between the supervisory authorities concerned.b. It ensures regular exchanges with research representatives and institutions.c. In cooperation with the ethics committees and, where appropriate, other supervisory authorities concerned, it issues recommendations on authorisation and notification procedures and on specific aspects of decision-making practice.d. It participates in the design and implementation of basic and further training for members of ethics committees.e. It provides information for the public, preparing in particular a summary of the annual reports submitted by ethics committees and a statistical overview of the research projects authorised.3 It may, within the framework of the operation of the portal and the supplementary federal database in accordance with Article 67 ClinO8, enable the electronic exchange of documents relating to the authorisation and notification procedures between applicants and authorisation authorities.4 It shall issue guidelines on the content of the reports to be submitted by ethics committees in accordance with Article 55 paragraph 2 HRA.8 SR 810.305Chapter 3 Data Protection  Art. 11 Disclosure of personal data  1 Before the enforcement body discloses personal data to the authorities responsible in accordance with Article 59 paragraphs 1 and 2 HRA, it shall solicit comments from the data subject, providing information at the same time on:a. the purpose of the disclosure of data;b. the nature of the data to be disclosed; andc. the data recipient.2 The obligations specified in paragraph 1 do not apply if:a. the data subject has already been adequately informed;b. the disclosure of data is evident from the circumstances of the particular case;c. there is an immediate risk of legal claims or important third-party interests being prejudiced, or the fulfilment of legal duties being prevented; ord. the data subject cannot be traced.3 If data is to be published under Article 59 paragraph 3 HRA, all items which, when combined, would enable the data subject to be identified without disproportionate effort, must be masked or deleted. These include in particular the name, address, date of birth and unique identification numbers.Art. 12 Exchange of data with foreign authorities and institutions  1 The following are empowered to exchange confidential data with foreign authorities and institutions or international organisations:a. the responsible ethics committee;b. the cantonal supervisory authority;c. the Swiss Agency for Therapeutic Products (Agency); andd. the FOPH.2 If the confidential data includes personal data, this may only be transmitted to foreign authorities and institutions or to international organisations if the privacy of the data subject is not seriously endangered thereby, in particular due to the absence of legislation that guarantees adequate protection.3 In the absence of legislation that guarantees adequate protection, personal data may only be transmitted abroad if:a. disclosure is required in order to protect the life or the physical integrity of the data subject;b. disclosure is essential in order to avert an imminent danger to public health;c. sufficient safeguards, in particular contractual clauses, ensure an adequate level of protection abroad; ord. the data subject has consented in the particular case.Chapter 4 Commencement  Art. 13 This Ordinance shall come into force on 1 January 2014.


text: 810.311 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Ordinanceon Research involving Embryonic Stem Cells(Stem Cell Research Ordinance, SCRO)of 2 February 2005 (Status as of 1 April 2012)The Swiss Federal Council,on the basis of Article 17 of the Stem Cell Research Actof 19 December 20031 (the Act),ordains:1 SR 810.31 Section 1: Informed Consent of the Couple Concerned  Art. 1 Determination of the surplus status of an embryo  If an embryo cannot be used to establish a pregnancy, the physician treating a couple in connection with an assisted reproduction procedure shall inform the couple:a.that it is a surplus embryo;b.why the embryo has become surplus; andc.that the surplus embryo will be destroyed unless it is used, subject to the conditions specified in the Act, for the derivation of stem cells with a view to the conduct of a research project (stem cell derivation) or for a research project aimed at improving derivation methods.Art. 2 Information to be provided for the couple concerned prior to consent  1 If a licence has been obtained for stem cell derivation or for a research project aimed at improving derivation methods, the physician shall verbally inform the couple concerned, in a comprehensible manner:a.about the nature, purpose and expected starting date of the intended research project;b.about the couple’s rights under Article 5 paragraph 3 of the Act and under paragraphs 3 and 4 of this Article;c.about the non-commercialism specified in Article 4 of the Act;d.about the measures provided for in Article 27 to protect the couple’s personal data;e.that third parties may acquire rights to stem cells or products derived therefrom, for example in accordance with the Patent Act of 25 June 19542, without any entitlements accruing to the couple as a result;f.that it is possible for stem cells or products derived therefrom to be used in clinical research and practice, without any entitlements accruing to the couple as a result;g.that, under Article 9 paragraph 1 letter c of the Act, the stem cells derived may be passed on for other research projects; andh.about the content of the written consent, as specified in Article 3.2 The physician shall provide the couple with an information sheet and an informed consent form made available by the person responsible for the research project (project manager).3 The couple have the right to put questions, or have questions put, to the project manager.4 The couple must be allowed an appropriate period for reflection on the decision concerning consent.2 SR 232.14Art. 3 Content of informed consent form  By signing the informed consent form, the couple concerned certify that they have received the information specified in Article 2 and that they consent to the use of the surplus embryo for stem cell derivation or for a research project aimed at improving derivation methods.Art. 4 Consequences of refusal or revocation of consent  If consent is refused or revoked by the couple concerned, or by the woman or the man, this may not prejudice the couple in relation to any subsequent treatment in the assisted reproduction procedure.Section 2: Licence for the Derivation of Embryonic Stem Cells  Art. 5 Application  When a licence is sought for stem cell derivation with a view to conducting a research project (Art. 7 of the Act), the following documents must be submitted to the Federal Office of Public Health (Federal Office) for review:a.complete documentation of the stem cell derivation project, including evidence of the suitability of the laboratory facilities;b.complete documentation for the research project involving embryonic stem cells, as submitted to the competent ethics committee in accordance with Article 17;c.the approval of the research project granted by the competent ethics committee;d.a statement, based on an extract from the registry specified in Article 18 of the Act, of the reasons why the embryonic stem cells available in this country are not suitable for the research project;e.information on the number of surplus embryos expected to be required.Art. 6 Review of the application  1 The Federal Office determines whether:a.the documents are complete;b.the licence conditions specified in the Act are met.2 It may request additional documents from the project manager.Art. 7 Review period  1 The Federal Office shall reach a decision within 60 days.2 If the Federal Office requests additional documents from the project manager, the review period begins as soon as the documents have arrived; it shall notify the project manager of the beginning of the period.Section 3: Licence for Research Projects aimed at improving Derivation Methods Art. 8 Application  When a licence is sought for a research project aimed at improving derivation methods (Art. 8 of the Act), the following documents must be submitted to the Federal Office for review:a.complete documentation for the research project, including evidence of the suitability of the laboratory facilities;b.an account of the extent to which the research project is expected to yield important findings for the improvement of derivation methods;c.a statement of the reasons why equivalent findings could not also be obtained in a different way, in particular through experiments involving animal embryos;d.information on the number of surplus embryos expected to be required;e.the information sheet and informed consent form.Art. 9 Review of the application  1 The Federal Office determines whether:a.the documents are complete;b.the information sheet and the informed consent form are complete and comprehensible;c.the licence conditions specified in the Act are met.2 It may request additional documents from the project manager.Art. 10 Review period  1 The Federal Office shall reach a decision within 60 days.2 If the Federal Office requests additional documents from the project manager, the review period begins as soon as the documents have arrived; it shall notify the project manager of the beginning of the period.Section 4: Licence for the Storage of Surplus Embryos  Art. 11 Application  When a licence is sought for the storage of surplus embryos (Art. 10 of the Act), the following documents must be submitted to the Federal Office for review:a.the licence granted under Article 7 or 8 of the Act;b.a statement of the reasons why storage of the surplus embryos is essential;c.evidence of the qualifications of the staff;d.evidence of the suitability of the laboratory facilities.Art. 12 Review of the application  The Federal Office determines whether:a.the documents are complete;b.the licence conditions specified in the Act are met.Section 5: Licence for the Import of Embryonic Stem Cells  Art. 13 Application  When a licence is sought for the import of embryonic stem cells (Art. 15 of the Act), the following documents must be submitted to the Federal Office for review:a.complete documentation for the research project involving embryonic stem cells, as submitted to the competent ethics committee in accordance with Article 17;b.the approval of the research project granted by the competent ethics committee;c.details of the number of embryonic stem cells or stem cell lines required and a characterisation thereof, as specified in Article 29 paragraph 1 letter b;d.evidence provided by the authority designated as competent under national legislation in the country concerned or recognised by that country to the effect that:1.the stem cells have been derived from surplus embryos,2.the couple concerned have freely given informed consent to the use of the embryo for research purposes, and3.the couple concerned are receiving no payment in return.Art. 14 Review of the application  The Federal Office determines whether:a.the documents are complete;b.the licence conditions specified in the Act are met.Section 6: Licence for the Export of Embryonic Stem Cells  Art. 15 Application  When a licence is sought for the export of embryonic stem cells (Art. 15 of the Act), the following documents must be submitted to the Federal Office for review:a.the title, objective and place of execution of the research project involving embryonic stem cells;b.the name and address of the project manager;c.the number of embryonic stem cells or stem cell lines to be exported and a characterisation thereof, as specified in Article 29 paragraph 1 letter b;d.evidence provided by the authority designated as competent under national legislation in the country concerned or recognised by that country, to the effect that:1.the project is designed to yield important findings with regard to the detection, treatment or prevention of serious human diseases or concerning human developmental biology, and2.the project has received ethical approval from an authority independent of the project manager.Art. 16 Review of the application  The Federal Office determines whether:a.the documents are complete;b.the licence conditions specified in the Act are met.Section 7: Assessment by the competent Ethics Committee and Authorisation of the Research Project Art. 17 Application  When an assessment is sought of a research project involving embryonic stem cells (Art. 11 of the Act), the following documents must be submitted to the competent ethics committee for review:a.complete documentation for the research project;b.a statement of the reasons why equivalent findings could not also be obtained in a different way;c.the information sheet and the informed consent form, if embryonic stem cells have to be derived for the research project.Art. 18 Review of the application  1 The ethics committee determines whether:a.the documents are complete;b.the conditions specified in the Act for the conduct of a research project with embryonic stem cells are met.2 If the research project is to be conducted at several centres, it suffices if an assessment is given according to the standard procedure by the ethics committee that is competent at the first centre; decisions may be reached by the other ethics committees concerned according to a simplified procedure. The project manager must submit the approval granted by the ethics committee competent at the first centre.3 For the evaluation of the research project, the ethics committee may consult experts and request additional documents from the project manager.Art. 19 Assessment period  1 The ethics committee shall issue its assessment within 30 days.2 If the ethics committee consults experts or requests additional documents from the project manager, the assessment period begins as soon as the experts’ comments or the documents have arrived; the ethics committee shall notify the project manager of the beginning of the period.Art. 20 Authorisation of the research project  1 Prior to the initiation of the research project, the project manager shall notify the Federal Office thereof and submit:a.the title of the research project, if the Federal Office has the project documents at its disposal in connection with the licensing procedure under Article 5 or 13;b.the complete documentation for the research project, as submitted to the competent ethics committee in accordance with Article 17, together with this committee’s approval, if embryonic stem cells available in this country are to be used for the project.2 The Federal Office may request additional documents from the project manager.3 Within 15 days of receipt of the notification or the necessary documents, the Federal Office shall assign a reference number to the research project, provided that it has no objections. It shall inform the project manager of the number.4 After the communication of the reference number, the research project may be initiated.Art. 21 Re-evaluation and withdrawal of approval  1 The ethics committee may re-evaluate a research project and if appropriate withdraw its approval, if this is necessitated by new scientific findings and a resultant change in the ethical assessment.2 It shall notify the project manager and the Federal Office immediately of the withdrawal of its approval.3 It shall inform the Federal Office immediately of any irregularities in the conduct of the research project.Section 8: Changes to the Project  Art. 22 1 Any person who derives embryonic stem cells, carries out a research project aimed at improving derivation methods, stores surplus embryos, or imports or exports embryonic stem cells must notify the Federal Office of any significant planned changes to the project concerned.2 Any person who carries out a research project involving embryonic stem cells must notify the ethics committee and the Federal Office of any significant planned changes to the research protocol.3 The Federal Office, or the ethics committee and the Federal Office, shall issue a response within 30 days of receipt of such notification.4 A project of the type specified in paragraph 1 may only be continued with the proposed changes if the Federal Office grants a new licence.5 A research project of the type specified in paragraph 2 may only be continued in accordance with the modified research protocol if the ethics committee renews its approval and the Federal Office renews its authorisation of the project.Section 9: Notification and Reporting Duties  Art. 23 Notification after discontinuation or completion of the project  1 Any person who derives embryonic stem cells or carries out a research project aimed at improving derivation methods must notify the Federal Office of the discontinuation or completion of stem cell derivation or the research project within 15 days.2 Any person who carries out a research project involving embryonic stem cells must notify the Federal Office and the ethics committee of the discontinuation or completion of the project within 15 days.3 If a project is discontinued, the reasons must be indicated in the notification.Art. 24 Final report  1 Any person who derives embryonic stem cells or carries out a research project aimed at improving derivation methods must submit a report to the Federal Office within six months of the discontinuation or completion of stem cell derivation or the research project.2 Any person who carries out a research project involving embryonic stem cells must submit a report to the Federal Office and the ethics committee within six months of the discontinuation or completion of the research project.3 The Federal Office may specify a shorter period if there is good cause for doing so; in response to a justified request from the project manager, it may in exceptional cases extend the period.Art. 25 Content of the final report  1 The final report must document the course and results of the embryonic stem cell derivation, or of the research project aimed at improving derivation methods or involving embryonic stem cells.2 The final report on embryonic stem cell derivation must also include the following details:a.the number of embryos used; andb.the number of embryonic stem cells derived, or the number of stem cell lines and a characterisation thereof, as specified in Article 29 paragraph 1 letter b.3 The final report on a research project aimed at improving derivation methods must also include the following details:a.the number of embryos used;b.the number of embryonic stem cells derived, or the number of stem cell lines and a characterisation thereof, as specified in Article 29 paragraph 1 letter b, if stem cells are derived in connection with the project; andc.a summary of the positive and the negative results.4 The final report on a research project involving embryonic stem cells must also include a summary of the positive and the negative results.Art. 26 Storage of embryonic stem cells  Any person who stores embryonic stem cells must notify the Federal Office annually, as at 1 July, of the total numbers of deposits and withdrawals, and of the number of stem cell lines stored and the characterisation thereof, as specified in Article 29 paragraph 1 letter b.Section 10: Data Protection  Art. 27 1 No data permitting identification of the couple concerned may be communicated to the persons involved in stem cell derivation or in research projects.2 The clinic performing the IVF procedure shall anonymise the data concerning the surplus embryo by the assignment of a code before passing on the embryo for stem cell derivation or for a research project aimed at improving derivation methods.3 It shall retain the data of the couple concerned, the information sheet, the original signed consent form and the code key for ten (10) years. The data security measures must conform to the current technical standards.Section 11: Public Registry  Art. 28 Purpose of the registry  The registry specified in Article 18 of the Act is intended in particular:a.to enable embryonic stem cells to be passed on for research projects carried out in this country, as specified in Article 9 paragraph 1 letter c of the Act;b.to permit assessment of whether embryonic stem cells suitable for a research project are available in this country;c.to provide an overview of ongoing and completed research projects in this country.Art. 29 Content of the registry  1 Any person who derives embryonic stem cells, carries out a research project aimed at improving derivation methods, or involving embryonic stem cells, or imports embryonic stem cells must submit the following information to the Federal Office:a.a description of the project in which the stem cells are derived or used, including the following details:1.title of the project,2.objective of the project,3.name and address of the project manager,4.starting date and expected duration of the project;b.a characterisation of the embryonic stem cells derived or used in the project, and of the stem cell lines used; stem cell lines are pluripotent cells derived from cells of an early embryo, which can be cultured in vitro and reproduced over generations, exhibiting a stable genotype and phenotype.2 The Federal Office shall include in the registry the information required by paragraph 1 letter a when a licence is granted under Articles 5, 8 or 13, or when a notification is received under Article 20.3 It shall publish in the registry the summaries specified in Article 25 paragraphs 3 letter c and 4.4 It may request clarification of the information submitted.Section 12: Charges  Art. 30 Calculation of charges  1 The charges are calculated according to the rates given in Article 31. Within the framework of these rates, the charges are set on the basis of the time required, taking account of the necessary expertise.2 For services not explicitly mentioned in Article 31, the level of the charge is based on the time required. The hourly rate, according to the expertise required and the functional level of the personnel involved, ranges from 90 to 200 Swiss francs.Art. 31 Rates of charges  The Federal Office levies the following charges in particular:Swiss francsa.3Licence for derivation of embryonic stem cells from surplus embryos: grant, renewal, suspension, revocation500 – 10 000b.4Licence for a research project aimed at improving derivation methods: grant, renewal, suspension,revocation500 – 10 000c.5Licence for the storage of surplus embryos: grant, renewal, suspension, revocation250 – 5 000d.6Licence for the import or export of embryonic stem cells: grant, renewal, suspension, revocation500 – 10 000e.Inspection (excluding preparation and report) per day1 000 – 20 000f.Certificates, reports200 – 2 0003 Amended by No I of the Ordinance of 2 March 2012, in force since 1 April 2012  (AS 2012 1201).4 Amended by No I of the Ordinance of 2 March 2012, in force since 1 April 2012  (AS 2012 1201).5 Amended by No I of the Ordinance of 2 March 2012, in force since 1 April 2012  (AS 2012 1201).6 Amended by No I of the Ordinance of 2 March 2012, in force since 1 April 2012  (AS 2012 1201).Art. 32 Surcharge  The Federal Office may levy a surcharge of up to 50 per cent of the charge if the service:a.is provided, on request, urgently or outside normal working hours;b.is exceptionally time-consuming or involves particular difficulties.Art. 33 Expenses  In addition to the charges levied, expenses relating to the individual service are invoiced. The following items are deemed to be expenses:a.fees for committee members, experts and representatives;b.costs occasioned by the collection of evidence, scientific studies, special investigations or the procurement of documents;c.travel and transport costs;d.costs of tests at internal or external laboratories;e.costs of work carried out by third parties on behalf of the Federal Office.Section 13: Forms  Art. 34 The Federal Office may prescribe forms:a.for the licensing procedures under Articles 5, 8, 11, 13 and 15;b.for the fulfilment of notification and reporting duties under Articles 20, 23 and 24;c.for the information to be collected for the public registry.Section 14: Commencement  Art. 35 This Ordinance comes into force on 1 March 2005.