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, hepatitis B, C and D tests, and blood group markers. The PEI-IVD has its own reference materials and international standards for testing.
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 Medical Devices at the Paul-Ehrlich-Institut.
The EU reference laboratory (EURL) at the Paul-Ehrlich-Institut is responsible for high-risk infection tests in the "Hepatitis and Retroviruses" and "Highly Pathogenic Respiratory Viruses" test categories.
Email: pei-ivd@pei.de
Updated: 24.01.2025
The Testing Laboratory for in Vitro Diagnostic Medical Devices at the Paul-Ehrlich-Institut (PEI-IVD) works with notified bodies in the EU:
The PEI-IVD makes the current price list for specific services available to its cooperation partners on request.
Email: pei-ivd@pei.de
Updated: 24.01.2025
The testing laboratory for in vitro diagnostics at the Paul-Ehrlich-Institut (PEI-IVD) is recognised 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).
The lab is accredited by the German Accreditation Body (DAkkS) as a testing laboratory according to DIN EN ISO/IEC 17025:2018
The PEI-IVD works with notified bodies on the basis of private law contracts, which regulate the nature and scope of cooperation, the use of 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).
Updated: 24.01.2025
The Testing Laboratory for in Vitro Diagnostic Medical Devices at the Paul-Ehrlich-Institut (PEI-IVD) is involved in the following cooperations and studies:
Updated: 24.01.2025
Reagents for the detection of
Updated: 24.01.2025
