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New Tasks and Competences for the Paul-Ehrlich-Institut Pursuant to the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR)

11 / 2022

  • The In Vitro Diagnostic Medical Devices Regulation enters into force on 26 May 2022. As of that date, SARS-CoV-2 tests will be classified in class D, the highest risk class, and are therefore subject to stricter certification regulations than previous.
  • Under the new regulation, the Paul-Ehrlich-Institut assumes additional tasks that ensure the safety and reliability of in vitro diagnostic medical devices.
  • The Institute has been responsible for the task of recording and assessing serious risks (test failure) of certain in vitro diagnostic medical devices since January 2002. Now that task has been extended to other products.

Quote Professor Cichutek

Press Release

As of 26 May 2022, Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation, will apply in the EU, replacing the previously applicable IVD Directive. The IVD Regulation assigns infection markers detected by tests for SARS-CoV-2 to class D, the highest risk class. The IVD regulation extends the competence of the Paul-Ehrlich-Institut to record and assess incidents of certain IVDs to include all class D test systems for the detection of life-threatening infections, pathogens transmissible through blood and tissue and a part of the risk class C test systems for the detection of sexually transmitted agents or congenital disorders in the embryo or foetus.

SARS-CoV-2 Antigen Tests to be Classified in the Highest Risk Class

An important change in accordance with the IVD Regulation compared to the IVD Directive, which remained in force until 25.05.2022 and its legal implementation in Germany, is that SARS-CoV-2 detection tests will be classified in class D, the highest risk class. One change initiated by this reclassification is that CE markings will only be awarded by a notified body after a conformity assessment procedure has been carried out, and no longer will be awarded by the manufacturer itself.

Due to bottlenecks at suitable notified bodies and because no EU reference laboratories have been designated, the EU Commission decided to allow SARS-CoV-2 tests for professional use that were self-certified through 25.05.2022 under the old Directive to stay on the market. These test systems can remain on the market until May 2025 without having to undergo the more stringent procedures under the IVD Regulation.

In vitro-Diagnocs (IVD): Tests and virtual data

Paul-Ehrlich-Institut to Approve Performance Evaluation Tests

The Paul-Ehrlich-Institut will take on new tasks in accordance with the new European IVD Regulation in conjunction with the Medical Device Law Implementing Act (MPDG).

Pursuant to section 31 of the MPDG or Annex XIV of the IVD Regulation, the Paul-Ehrlich-Institut will become the competent higher federal authority for the approval of IVD performance evaluation tests in Germany and interventional clinical performance studies of IVDs. Such performance evaluation tests, which are examined in parallel by an ethics committee, will be the prerequisite for an IVD to obtain CE certification necessary for marketing.

The Paul-Ehrlich-Institut makes decisions on the classification of specific IVDs and their distinction from other test systems at the request of a competent state authority, a notified body or an IVD manufacturer.

Additional Measure Taken on in Germany: Paul-Ehrlich-Institut to Maintain the Market Overview of SARS-CoV-2 Antigen Tests

As of 26 May 2022, manufacturers of SARS-CoV-2 antigen tests who want to have their test included in the market overview of the SARS-CoV-2 antigen tests that are reimbursable according to section 1 sentence 1 of the Coronavirus Testing Ordinance (TestV) must submit applications to the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, in Langen (Hesse).

In order to be included in the market overview, the test must have been legally placed on the market in Germany in accordance with the provisions of the Medical Devices Act (MPG) and must meet the current minimum criteria established by the Paul-Ehrlich-Institut (PEI) in coordination with the Robert Koch-Institut (RKI).

The tables of such antigen tests (Market Overview), both for professional and personal use, will be maintained by the Paul-Ehrlich-Institut in the future. For technical reasons, the lists will remain on the website of the BfArM for a transitional period.

The Paul-Ehrlich-Institut will also continue to carry out a comparative experimental evaluation of antigen tests on a random basis. The results will be displayed in a separate table. Manufacturers and distributors of IVD are not entitled to have their IVD product taken into account in this evaluation.

Updated: 30.05.2022