Testing Laboratory for in-vitro Diagnostic Medical Devices at the Paul-Ehrlich-Institut (PEI-IVD)
- Mission and Purpose
- Services of PEI-IVD
- Organisation of PEI-IVD
- Performance data
- Quality Assurance
- Cost effectiveness
- Collaborations and studies
- Work in boards and committees
- Co-operation Partners
- Markers with Accreditation at PEI-IVD in accordance with the Directive 98/79/EC
Mission and Purpose
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 (IVD Directive) regulates the marketing and CE labeling on in-vitro diagnostic medical devices in Europe.
A testing laboratory for in-vitro diagnostic medical devices (PEI-IVD) was established at the Paul-Ehrlich-Institut pursuant to Section 32 (2) German Medicinal Products Act (Medizinproduktegesetz). PEI-IVD is professionally independent and collaborates with notified bodies and other organizations. The purpose of the testing laboratory is to benefit from the existing competence and the long-lasting experience that PEI has in the field of the marketing authorisation and batch control of in-vitro diagnostic medical devices and to maintain the high safety standard of the IVDs. For its work as testing laboratory at the EU level, PEI-IVD received its accreditation from the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices) pursuant to DIN EN ISO 17025 for the first time on 10 November 2000.
Above all the testing laboratory tests IVD which must be CE marked by a "Notified Body" pursuant to Annex II of the IVD Directive, e.g. HIV, HTLV and Hepatitis B, C and Delta tests. Tests comprise batch verification and product evaluations within the framework of the conformity evaluation procedure. In addition, PEI-IVD also conducts scientific studies and evaluates products upon request from the manufacturers or further organizations (see "Services").
During the 25 years in which responsibility for these products lay with PEI, a high standard of safety was achieved for blood and blood products. It is our aim to also maintain the high degree of health protection that has been reached, now that the IVD Directive has been adopted.
PEI-IVD collaborates with Notified Bodies throughout Europe. In doing so, it provides experts for conformity assessment of in vitro diagnostic medical devices pursuant to Annex II of Directive 98/79EC (IVD Directive) and performs batch verification of IVDs pursuant to Annex IV 6. and Annex VII 5. of the IVD Directive.
In principle, the scope of services includes:
- Laboratory tests performed on the products manufactured pursuant to Annex IV 6. and Annex VII 5. of the IVD Directive as subcontractor of the Notified Bodies including assessment of the quality control documents from the manufacturers ("batch control testing").
- Expert assessment of the performance of products listed in Annex II Lists A and B pursuant to Annexes IV and V of the IVD Directive.
- Tests on products of Annex II for conformity with the requirements of the Directive and the Common Technical Specifications (CTS).
- Performance evaluation studies of screening tests.
- Assessment and testing of diagnostic devices as contractor for the competent authorities to clarify reasons for test failures and malfunctions.
The services in concrete terms are laid down in a price list which can be provided to the co-operation partners upon request. All services are provided in a neutral fashion and treated with equal priority.
Personnel, rooms, equipment, reference material
To fulfil the tasks of testing IVDs, PEI-IVD currently employs 8 scientists and 16 technicians. PEI-IVD has laboratories in which all equipment and analysis machines are available for the testing of:
- Serological kits
- Kits for blood group determination and
- Nucleic Acid Amplification (NAT) methods
For the testing of the IVDs, PEI-IVD has its own reference materials and international standards for the following markers:
- HIV 1/2
Order list for commercial reference materials
In addition, PEI-IVD has a considerable number of commercially available sample panels and own characterized samples which are used for performance assessment and the testing of manufactured products.
Organisation of PEI-IVD
Around 800 different in-vitro diagnostic devices have been assessed so far. Testing orders could be obtained for a large quantity of products subject to Annex II, List A of the IVD Directive.
The capacity for testing is 2000 product batches per annum. Provided that PEI-IVD receives all reagents from the manufacturer in a timely manner and no delays occur due to problems with the equipment, PEI-IVD can guarantee a maximum delivery period for its test results of two weeks (10 working days). The average test period is 3-5 working days.
PEI-IVD has a complex quality assurance system:
- Recognition by the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (Central Authority of the Länder for Health Protection Regarding Medicinal Products and Medical Devices) in accordance with the standard DIN EN ISO/IEC 17025 and Directive 98/79/EC.
- Participation in collaborative studies of INSTAND: viral immunology, NAT, parasitology I (toxoplasmosis), bacteriology (chlamydia) and haematology II.
- Participation in the programs of WHO for the development of HIV, HBV, HCV and other international standard materials.
PEI-IVD operates in accordance with private law. The type and scope of collaboration, utilization of services, and remuneration are laid down in contracts. Prices are calculated in such a way that they cover the expenses subject to market conditions. PEI-IVD does not operate in a profit-oriented manner and is treated as a "business with commercial character" (Betrieb gewerblicher Art) from the point of view of taxation in Germany.
Collaborations and studies
PEI-IVD participates in the following collaborations and studies:
- Collaborating Center for the International Consortium of Blood Safety (ICBS)
- PEI-WHO Collaborating Center
- Evaluation of seroconversion sensitivity of screening tests
- Reference laboratory for INSTAND (www.instandev.de)
Work in boards and committees
PEI-IVD contributes work to the following national and international bodies:
- Sectoral Committee of the ZLG In Vitro diagnostic Medical Devices (SK-6)
- Diagnostics Committee of the German Association against Virus Diseases/ Society for Virology (Diagnostikaausschuss der Deutschen Vereinigung zur Bekämpfung von Viruskrankheiten und der Gesellschaft für Virologie, DVV/GfV)
- IVD-Technical Group (IVD-TG) of the EU Commission in Brussels
- Specialist Advisory Group (Fachbeirat) 3 Health and Forensics of the Accreditation Council (Akkreditierungsbeirat)
|Notified Body (in alphabetical order)||Identification Number|
|British Standards Institution (BSI); |
Hertfordshire HP2 4SQ UK
|BSI Group Deutschland GmbH, Eastgate, |
Hanauer Landstraße 115, 60314 Frankfurt
|DEKRA Certification B.V.,|
6812 R Arnhem, The Netherlands
|Lloyd's Register Quality Assurance (LRQA) Ltd.,|
UK-CV3 4FJ Coventry, UK
|mdc medical device certification GmbH, 70191 Stuttgart||CE 0483|
|SGS United Kingdom Limited |
202B Worle Parkway Weston Super Mare BS22 6WA; UK
|TÜV Austria Services GmbH, A-1010 Wien||CE 0408|
|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|
Markers with Accreditation at PEI-IVD in accordance with the Directive 98/79/EC
- HIV 1/2
- HTLV I/II
- Hepatitis B, C, D
- Blood Groups: AB0, Rhesus (C,c,D,E,e), Anti-Kell
- Rubella, Toxoplasmosis, Cytomegalovirus, chlamydia
- Duffy-System, Kidd-System
- Irregular anti-erythrocytic antibodies