13 / 2023
"We are pleased that, with the intensive support of the Federal Ministry of Health, other stakeholders in Europe were convinced of the added value of independent laboratory testing of in vitro diagnostic devices by EU reference laboratories. At the Paul-Ehrlich-Institut, we are very well positioned to perform EU reference laboratory tasks because we can build on the decades of expertise and experience of our IVD testing laboratory employees as well as our existing infrastructure."
Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut
"We have successfully passed the European Commission's thorough selection process in cooperation with the Federal Ministry of Health and are pleased to be able to use our expertise in virology and microbiology as an EU reference laboratory (EURL) for infection diagnostic tests. In view of our employees' high levels of experience and motivation, I am very confident that the EURL model will be a successful one and that the Paul-Ehrlich-Institut will play a leading role for Europe in this area."
Dr Micha Nübling, EURL project head at the Paul-Ehrlich-Institut
In a legislative act dated 5 December, 2023, the European Commission announced their designation of the EU reference laboratories (EURL) for in vitro diagnostic medical devices (IVDs) under the European IVD Regulation (EU) 2017/746. The Paul-Ehrlich-Institut's application received consistently positive evaluations. As a result, the Paul-Ehrlich-Institut has now become an EU reference laboratory for two important groups of devices known as high-risk infection tests: test category "hepatitis and retroviruses" and test category "respiratory viruses". Test category "hepatitis and retroviruses" contains the most important pathogens for which biological drugs undergo tests with regard to their viral safety. The list of pathogens includes the human immunodeficiency virus (HIV) and hepatitis viruses. Blood and plasma donations are tested for these pathogens as are other significant medical products of human origin, such as cell preparations or transplants. The importance of the detection of pathogens such as SARS-CoV-2, currently the most important representative from test category "respiratory viruses", became clear during the pandemic. After a transitional phase for final preparations and networking with the other EURLs, the EURL at the Paul-Ehrlich-Institut will start testing IVDs on 1 October, 2024.
For decades leading up to the year 2000, the Paul-Ehrlich-Institut was responsible for the testing and batch testing of IVDs for the German market as a testing laboratory under the then valid IVD legislation. Starting in December of 1999, organisations known as notified bodies (e.g. TÜV) took over the task of evaluating IVDs under the European IVD Directive 98/79/EC (In Vitro Diagnostic Device Directive, IVDD). Since then, the Paul-Ehrlich-Institut has been testing product batches on behalf of notified bodies as a testing laboratory. Thus, the expertise built up over decades in the testing and evaluation of IVDs at the Paul-Ehrlich-Institut has been retained. This knowledge has become a unique characteristic of the Paul-Ehrlich-Institut amongst European authorities. In the pandemic, the Paul-Ehrlich-Institut took on the task assigned by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) to test the sensitivity of SARS-CoV-2 tests on an ad hoc basis. The European regulation for in vitro diagnostic medical devices (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation, IVDR) replaced the IVD Directive and has been in force since 2022. The regulation brings with it some improvements in the regulatory control of IVDs. Such improvements include the establishment of official EU reference laboratories, which are intended to confirm the reliability of IVDs and their fulfilment of specific performance requirements through laboratory tests before they reach the European market.
An EURL handles a diverse range of tasks. Firstly, the product quality of new IVDs must be examined and the manufacturer's performance specifications must be independently confirmed in the laboratory. Only after the EURL issues a positive recommendation can the notified body then complete the certification process (CE marking) for an IVD. Later, the EURL conducts batch testing to ensure consistent quality of the product batches on the European market. Last but not least, EURLs are obliged to advise various stakeholders (European Commission, notified bodies, competent authorities) with their expertise.
Together with the other EURLs, the Paul-Ehrlich-Institut is committed to making IVDs even safer and ensuring their high quality. Doing so will provide an even higher level of protection to patients. A task requiring immediate action after the designation is the formation of a European network with the other designated EURLs in order to determine the most uniform procedures possible between the EURLs.
Updated: 06.12.2023
