PEI IVD Testing Laboratory
On 26 May 2022, the In Vitro Diagnostic Medical Devices (IVD) Directive (98/79/EC) was replaced by Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices (IVD Regulation) and the Medical Devices Act (Medizinproduktegesetz, MPG) was replaced by the Medical Devices Implementation Act (Medizinprodukte-Durchführungsgesetz, MPDG). The testing laboratory for in vitro diagnostic medical devices at the Paul-Ehrlich-Institut (PEI-IVD), which was established at the Institute in accordance with the MPG (section 32 (2)), has been testing exclusively previously certified IVD products (existing products) in accordance with the transitional provisions of the IVD Regulation pursuant to article 110 (2) since the regulation came into force. IVDs that fall within the testing area of the testing laboratory and that have a certificate from a notified body pursuant to IVD Directive 98/79/EC can be tested by the testing laboratory through 25 May 2025 at the latest. The testing laboratory is still recognised as the competent body for this activity by the Central Office of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) pursuant to IVD Directive 98/79/EC and DIN EN ISO/IEC17025.
The PEI IVD tests batches of IVD products that are CE-marked by a notified body in accordance with Annex II, List A of the IVD Directive. These include products such as HIV, HTLV, and hepatitis B, C and D tests.
The PEI IVD also conducts scientific studies and cooperates with other organisations; for example, it is part of the WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices at the Paul-Ehrlich-Institut.
Prospects for the Future
There are plans in place at the Paul-Ehrlich-Institut to use the PEI IVD's expertise and many years of experience in the field of IVD evaluation and batch testing to carry out the tasks of an EU reference laboratory detailed in Article 100 of the IVD Regulation. This will help maintain the high quality standards of IVDs under the new IVD Regulation. Accreditation through the German Accreditation Body (Deutschen Akkreditierungsstelle, DAkkS) in accordance with DIN EN ISO 17025 was completed in 2022 in addition to the ZLG's recognition in accordance with IVD Directive 98/79/EC and DIN EN ISO/IEC 17025. These were completed to clear the way for the PEI applying as an EU reference laboratory in 2023.
Over its more than 30 years of responsibilities in the field of high-risk diagnostics - first pursuant to the German Medicinal Products Act (Arzneimittelgesetz, AMG), then according to the IVD Directive 98/79/EC – the Paul-Ehrlich-Institut has been able to contribute to the high safety standards for blood and blood products. The aim is to maintain the level of health and safety previously achieved, along with the high quality standards that allow existing products manufactured in accordance with the IVD Directive to continue to be placed on the market for a transitional period, even after the IVD Regulation (EU) 2017/746 came into force.
Organisation of the Testing at the Paul-Ehrlich-Institut
Presentation of the organisation of the PEI-IVD, QMB: Quality Management Officer, NAT: Nucleic Acid Amplification Technology
Dr Heinrich Scheiblauer
Phone: +49 (0) 6103 77 7018
The PEI IVD works with notified bodies in the EU.
- Laboratory tests on behalf of notified bodies for the inspection of IVD products manufactured in accordance with Annex IV Number 6 and Annex VII Number 5 of the IVD Directive, including the evaluation of the manufacturer's quality control documents ("=batch inspection")
- Evaluation and testing of diagnostics on behalf of competent authorities to clarify test failures and malfunctions.
PEI IVD makes its price list available to its cooperation partners on request for specific services.
Personnel, Rooms, Equipment, Reference Material
The PEI IVD currently employs 11 scientists and 22 technical staff in order to complete all tasks required for the examination of IVDs. The PEI IVD has laboratories with all the necessary equipment and analysis machines for the testing of
- serological kits,
- blood-typing kits; and
- Nucleic acid amplification techniques (NAT).
The PEI IVD has its own reference materials and international standards for testing.
The PEI IVD also has a variety of commercially available sample panels and its own characterised samples that are used to test the manufactured IVD products and their performance.
Facts and Figures
More than 1000 different IVDs have been evaluated thus far. The PEI IVD was able to acquire a large share of the IVD products listed in Annex II, List A of the IVD Directive and certified in the EU.
The testing capacity of the PEI IVD laboratory is approximately 2000 product batches per year. If all reagents are delivered on time by the manufacturer and there are no delays due to problems with equipment, the PEI IVD can guarantee an average test duration of two weeks (10 working days) - whereby the actual average test duration is usually less.
- Recognition as a testing laboratory in accordance with IVD Directive 98/79/EC and DIN EN ISO/IEC 17025 by the Central Office of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG)
- Accreditation by the German Accreditation Body (DAkkS) as a testing laboratory according to DIN EN ISO/IEC 17025:2018
- Participation in INSTAND interlaboratory tests: virus immunology, nucleic acid amplification techniques (NAT), immunohaematology II
- Participation in WHO programmes for the development of HIV, HBV, HCV, SARS-CoV-2 and other international standard materials
The PEI IVD operates on the basis of private law. The nature and scope of its cooperation, the use of its services and any remuneration to be paid are all regulated by contracts. The prices are calculated in such a way that the PEI IVD can cover costs under the economic conditions at that time. It is not profit-oriented and is treated for tax purposes as a "commercial business" (Betrieb gewerblicher Art).
Cooperations, Committees and Studies
The PEI IVD is involved in the following collaborations and studies:
- PEI-WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Medical Devices
- Evaluation of seroconversion sensitivity of screening tests
- INSTAND reference laboratory
- Blood Proficiency Testing Scheme (B-PTS) of the European Directorate for the Quality of Medicines & HealthCare (EDQM)
National and International Committee Involvement
Member of the following working groups of the European Commission's Medical Device Coordination Group:
- New technologies
- In vitro diagnostic medical devices (IVD)
|Notified bodies ||Identification number|
|BSI Group The Netherlands B.V. |
John M. Keynesplein 9, 1066 EP Amsterdam
|DEKRA Certification B.V.,|
6812 R Arnhem, The Netherlands
|mdc medical device certification GmbH, 70191 Stuttgart||CE 0483|
|TÜV Rheinland LGA Products GmbH, 51105 Köln ||CE 0197 |
|TÜV SÜD Product Service GmbH, 80339 München ||CE 0123|
|UL International (UK) Ltd., Guildford Surrey GU3 1LR, UK||CE 0843|