s products like blood lancets and oral swabs.
General Laboratory Use Products
Products for general laboratory use are specifically excluded from the definition of IVD devices in the IVD Directive, unless the manufacturer intends that they be used specifically for in vitro diagnostic examination.3 General laboratory equipment is those products that can be used in a laboratory for essentially any purpose, including preparing samples. MEDDEV 2.14/1 rev. 2 gives examples of general laboratory equipment, like general centrifuges, pipettes, plastic tubes, empty ELISA plates and petri dishes, scales, and mass spectrometers. What will bring these products into the scope of the IVD directive is the intended purpose: plastic tubes for the purpose of collecting human blood are IVDs, whereas plastic tubes for any use are general laboratory products.
Law Enforcement Drug Tests and Biological or Chemical Warfare Agents
For a product to be considered an IVD within the scope of the IVD Directive, it must have a medical purpose. Law enforcement is not a medical purpose according to MEDDEV 2.14/1 rev. 2. As such, devices that are intended to be used only in the course of law enforcement are not IVDs within the scope of the IVD Directive. Likewise, paternity tests or drug tests used by company’s HR departments are also not IVDs within the scope of the IVD Directive. For this same reason, devices for detection of agents of biological or chemical warfare are not IVDs within the scope of the IVD Directive because they don’t have a medical purpose. An example of these types of devices is the swabs used by airport security screeners to test for residues on hands and suitcases.
Kits with IVDs
IVDs are sometimes used in conjunction with other products, together known as kits. Depending on what those other products are, the entire kit is considered to be an IVD within the scope of the IVD Directive, or only the IVD itself is considered while the other parts fall under another regulation. According to MEDDEV 2.14/1 rev. 2, kits are classified and assessed according to the principal intended purpose of the combination, and it is the entire kit that would receive the CE marking. However, sometimes kits include products that clearly are not included in the scope of the IVD Directive, like medical devices or general laboratory products. For IVD kits that include medical devices, the medical devices themselves must be CE-marked according to the Medical Devices Directive, and then the combination would be CE-marked according to the IVD Directive. General laboratory products can also be included in kits with IVDs, but wouldn’t be CE-marked in their own right.
The proposed EU regulations on IVDs aim to erase some of these borderlines by specifically including, or excluding, some borderline IVDs. In the meantime, however, relying on LNE/G-MED’s regulatory guidance and the medical purpose of the product could help an IVD manufacturer to define what type of product they have.
For more information on the services that LNE/G-MED offers to IVD manufacturers, contact us.
1 Guidance on legislation: Borderlines between medical devices and medicinal products, MHRA. Guide to Cosmetic Biocide Borderline Products. Irish Medicines Board.
2 98/79/EC Art. 2(b).