PEI IVD Testing Laboratory
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 section 32 subsection 2 of the MPG, has been testing already certified IVD products (existing products) with a certificate from a notified body in accordance with the IVD Directive 98/79/EC. These tests were carried out in accordance with the transitional provisions of the IVD Regulation pursuant to article 110 (2) and began when the regulation came into force. 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.
EU Reference Laboratory
In accordance with the EU implementing act 2023/2713, the Paul-Ehrlich-Institut was designated on 5 December, 2023, as the EU reference laboratory for two important categories of high-risk infection tests: the "Hepatitis and Retroviruses" test category and the "Highly Pathogenic Respiratory Viruses" test category. After a prescribed transitional period lasting until 1 October, 2024, the EU reference laboratory will begin testing. The PEI IVD's many years of expertise and experience in the field of IVD evaluation and batch testing - initially under the Medicinal Products Act (AMG), 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 at the Paul-Ehrlich-Institut. The lab will this assist in maintaining the high quality standard of IVDs in the future under the IVD Regulation, even after the IVD Directive (98/79/EC) expires.
Contact
Email: pei-ivd@pei.de
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Services
Services
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").
The PEI IVD can also carry out tests on behalf of competent authorities in the event of test failures and malfunctions of in vitro diagnostic medical devices.
Price List
The PEI IVD makes its price list available to its cooperation partners on request for specific services.
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Facilities
Facilities
Personnel, Rooms, Equipment, Reference Material
The PEI IVD currently employs 11 scientists and 23 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.
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Facts and Figures
Facts and Figures
More than 1,000 different in vitro diagnostic medical devices (IVDs) have been evaluated to date. 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 2,000 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.
Quality Assurance
- 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
Economic Efficiency
The PEI IVD works with notified bodies on the basis of private law contracts, which regulate the nature and scope of its cooperation, the use of its services and any remuneration to be paid. 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).
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Cooperations, Committees and Studies
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
The PEI IVD is a member of the following working groups of the European Commission's Medical Device Coordination Group:
- Standards
- New technologies
- In vitro diagnostic medical devices (IVD)
Cooperation Partners
Notified bodies | Identification number |
---|
BSI Group The Netherlands B.V.
John M. Keynesplein 9, 1066 EP Amsterdam | CE 2797 |
DEKRA Certification B.V.,
6812 R Arnhem, The Netherlands | CE 0344 |
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 |
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Scope
Scope
List A
Reagents for the detection of
- HIV 1/2
- HTLV I / II
- Hepatitis B, C, D
- Blood types: ABO system, Rhesus (C,c,D,E,e), Anti-Kell
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