In accordance with the EU Implementing Regulation 2023/2713, the Paul-Ehrlich-Institut was designated on 5 December 2023, as an EU reference laboratory (EURL) for in vitro diagnostic medical devices (IVDs) for two important class D product groups, which are known as high-risk infection tests:
The EU reference laboratory, which began operations on 1 October 2024, primarily assumes advisory tasks as well as tasks associated with conformity assessments.
The many years of expertise and experience of the in vitro diagnostic medical devices testing laboratory at the Paul-Ehrlich-Institut (PEI-IVD) in the area of evaluation and batch testing of IVDs – initially under the Medicinal Products Act (AMG) and then pursuant to the IVD Directive 98/79/EC – are now being used to carry out the tasks of an EU reference laboratory in accordance with Article 100 of the EU IVD Regulation 2017/746. The lab will assist in maintaining the high quality standard of IVDs in the future under the new IVD Regulation (2017/746), even after the IVD Directive (98/79/EC) expires.
The EU reference laboratory works with EU notified bodies in the "Hepatitis and Retroviruses" and the "Highly Pathogenic Respiratory Viruses" test categories.
The tasks of the EU reference laboratory are defined in Regulation (EU) 2017/746, Article 100 (2) a-j:
a) Verifying the performance and safety of class D products in accordance with regulatory requirements
b) Carrying out random tests on class D products and batches
c) Providing scientific and technical support to the EU Commission, Medical Device Coordination Group, and notified bodies
d) Providing scientific advice on the state of the art for specific products or product categories
e) Establishing and managing a network of national reference laboratories
f) Contributing to the development of test and analysis procedures for conformity assessment procedures and market surveillance
g) Working with notified bodies to develop best practices for conducting conformity assessment procedures
h) Recommending suitable reference materials and reference measurement methods of higher metrological order
i) Contributing to the development of common specifications and international standards
j) Preparing and publishing scientific opinions at the request of notified bodies, taking into account national confidentiality provisions
According to IVD regulation 2017/746, Article 100 (2h), EURLs have to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order for their specific scopes. The purpose of sharing this information is that class D IVD stakeholders have availability of references regarding standards and metrological traceability of IVD devices.
Recommendations on suitable reference materials and reference measurement procedures of higher metrological orderThe fees charged by the EU-IVD reference laboratory are governed by Implementing Regulation (EU) 2022/945.
Fees are calculated on the basis of the costs incurred, which in turn are based on the calculated average costs in the respective category.
The fees cover the following cost categories (Implementing Regulation (EU) 2022/945, Article 1):
a) Staff costs, including travel and related accommodation and subsistence costs
b) Equipment costs, where the equipment is not provided by the manufacturer of the device to be tested
c) Costs of consumables, test specimens and reference materials
e) Shipping costs for samples
f) Translation costs
g) General costs of the operation of the laboratory
The rules for the calculation of fees shall be reviewed regularly, at the least every two years, and adjusted if necessary.
The fees charged are non-discriminatory, fair, reasonable and proportionate to the services rendered (Implementing Regulation (EU) 2022/945, Article 2).
The price list of the EU reference laboratory for IVDs will be made available for specific services at the request of cooperation partners.
E-mail: eurl-ivd@pei.de
Funded by the European Union. However, the views and opinions expressed are solely those of the author(s) and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.
Source: EU
Updated: 05.03.2025
