What are the tasks of the Paul-Ehrlich-Institut and notified bodies in regards to the CE marking of in vitro diagnostics such as SARS-CoV-2 antigen tests?

The European In Vitro Diagnostic Medical Device Regulation (IVDR; Regulation EU 2017/746) changed the conditions for the CE marking (marketability) of in vitro diagnostic medical devices (IVD).

In the past, all IVDs not listed in Lists A or B of the previous IVD Directive 98/79/EC (In Vitro Diagnostic Device Directive, IVDD) could be placed on the market exclusively by the manufacturer on the basis of a declaration of conformity (self-certification). This was the cases for the majority of IVDs.

Under the new IVDR requirements, a conformity assessment procedure by a notified body is expected to be required for the majority of IVDs. In order to undergo the conformity assessment procedure, the manufacturer must submit the technical documentation for their IVD, e.g. a SARS-CoV-2 antigen test, to a notified body. On the basis of the technical documentation, the notified body then checks whether the product meets the basic safety and performance requirements detailed in the IVDR. If the requirements have been met, the notified body will issue a CE mark for the IVD. The CE mark signifies that the product conforms with the applicable requirements.

Performance assessment tests serve as a basis for the CE mark. These tests are used to assess and analyse data to determine or verify the scientific validity, analytical performance and, where applicable, the clinical performance of a device. This data is collected on the basis of performance studies that manufacturers are required to carry out. The studies may only be performed if they have been previously approved by the competent authority and an ethics committee. The competent authority in Germany, depending on the IVD, is either the Paul-Ehrlich-Institut or the Federal Institute for Drugs and Medical Devices (BfArM). During the approval process, these authorities check for elements such as whether the study is structured in such a way that it meets all the requirements of IVDR. The Paul-Ehrlich-Institut is responsible for Class D IVDs and certain Class C IVDs (all IVDs covered by Rules 1, 2 and 3 (a) to (e) and (g) of Annex VIII to Regulation (EU) 2017/746). The BfArM is responsible for all other IVDs included in the EU regulation. The Paul-Ehrlich-Institut or the BfArM authorises the performance evaluation tests, but does not carry out any evaluations itself and does not award CE marks. Independent examinations by the Paul-Ehrlich-Institut, such as examinations of SARS-CoV-2 antigen tests newly placed on the market, are no longer necessary due to the conformity assessment of the notified bodies.

A CE mark must be affixed to the outer packaging of the IVD and must always include the four-digit identification number of the notified body that issued the CE mark.