The In Vitro Diagnostic Medical Devices Regulation EU 2017/746 (IVDR) replaced the IVD Directive 98/79/EC (IVDD) on 26 May, 2022. Within the new regulation, the Paul-Ehrlich-Institut has been given additional IVD vigilance responsibilities, such as the evaluation of performance studies.
The European In Vitro Diagnostic Medical Devices Regulation (IVDR; Regulation EU 2017/746) changed the conditions for the CE marking—and thus also for the marketability—of in vitro diagnostic medical devices (IVD). The IVDR came into force on 26 May, 2017, with a transitional period of up to five years after the start of validity on 26 May, 2022.
Since 26 May, 2022, most new IVDs have not been certified by the manufacturers themselves. They are instead subject to a conformity assessment procedure by a notified body. This procedure evaluates the technical documentation to check 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.
CE marking is based on performance studies that evaluate scientific validity, analytical performance, and clinical performance (when applicable). Manufacturers are obliged to carry out these tests in the form of performance studies. Prior approval of these studies by the competent authority and an ethics committee is required in some cases. The criteria to be met for the approval of such studies are set out in the IVD Regulation.
The Paul-Ehrlich-Institut, as a competent authority in Germany, assesses points such as whether the study is structured to meet all of the IVDR requirements.
Since 1 January, 2002, the Paul-Ehrlich-Institut has also been the competent higher federal authority for the centralised collection and assessment of serious risks connected to certain IVDs.
The competence of the Paul-Ehrlich-Institut in the context of IVD vigilance from 1 January, 2002 to 25 May, 2022 was essentially limited to screening tests used to release blood and tissue components, and thus restricted to the IVD products in lists A and B of Annex II of the previously applicable European IVD Directive (IVDD).
The Paul-Ehrlich-Institut's tasks include the recording of incident reports and IVD recalls by manufacturers, operators, and users. The Institute carries out risk assessments of these incidents and assesses the benefits of the corrective or preventive actions proposed by the manufacturer.
When the IVDR became valid, the competence of the Paul-Ehrlich-Institut expanded to all class D products (life-threatening infections, pathogens transmissible through blood and tissue, blood groups) and some of the class C products (e.g. sexually transmitted infections). The class D list includes products such as SARS-CoV-2 detection tests. The Paul-Ehrlich-Institut approves the performance tests, but does not carry out any evaluations itself and does not award CE marks.
Since the IVDR, the Testing Laboratory for In Vitro Diagnostics at the Paul-Ehrlich-Institut (PEI-IVD) has been testing exclusively certified IVD products (existing products) on the basis of the transitional provisions of the IVDR. These tests will end by 25 May, 2025, at the latest.
With our many years of expertise and experience in the evaluation and batch testing of IVDs, we will continue to contribute to the high quality standards of IVDs under the new IVD Regulation. As it possess the necessary qualifications, the Paul-Ehrlich-Institut will apply as an EU IVD reference laboratory in 2023.
Dr Heinrich Scheiblauer (Head of the PEI IVD Testing Laboratory)