Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten

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ZLG Illustrationen aus dem Bereich Arzneimittel und MedizinprodukteZLG Illustrationen aus dem Bereich Arzneimittel und MedizinprodukteZLG Illustrationen aus dem Bereich Arzneimittel und Medizinprodukte

Designation of conformity assessment bodies

The unit "conformity assessment bodies" evaluates the competence of German bodies to carry out tests and certifications in accordance with third country law. Following a successful appraisal, the bodies are designated by ZLG in agreement with ZLS according to § 15a of the German Medical Devices Act as conformity assessment body.

Dr Ulrich Poos is responsible for the unit and is available to answer your technical queries.

EC agreements with third countries

The Mutual Recognition Agreements on Conformity Assessment (MRAs) form the basis of the designation of conformity assessment bodies. In addition to other areas, these MRAs con tain the area of medical devices.

These agreements stipulate that the authority in the importing country recognises the evaluation of a medical device or quality management system conducted by a conformity assessment body located in the exporting country. This means that European manufacturers of medical devices could receive confirmation of compliance with third country regulations from European conformity assessment bodies.

The agreements imply the mutual acceptance of conformity assessment bodies and systems. However they do not imply mutual recognition (harmonisation) of regulation. Thus the regulations of the importing contract party continue to be valid.

The benefit associated with the agreements is primarily the availability of local contacts for non-EC markets and the opportunity to communicate in the national language. In the long term, it is hoped that there will also be a noticeable reduction in external audits/inspections.

In the medical devices sector the following agreements have currently been made with the European Community with regard to the mutual recognition of conformity assessment:

  • Australia
    Agreement on mutual recognition in relation to assessment, certificates and markings

    source OJ L 229 of 17 Aug 1998

  • Canada
    Agreement on mutual recognition

    source OJ L 280 of 16 Oct 1998

  • New Zealand
    Agreement on mutual recognition of conformity assessment

    source OJ L 229 of 17 Aug 1998

  • Switzland
    Agreement on mutual recognition in relation to conformity assessment

    source OJ L 114 of 30 Apr 2002

  • United States of America
    Agreement on mutual recognition

    source OJ L 31 of 4 Feb 1999

The texts of the agreements as well as further information can be found on the European Commission's website.

The requirements and procedures for the acceptance of conformity assessment bodies are dependent upon the agreement. The following have been identified as confidence-building measures for quality assurance:

  • seminars about regulatory systems, procedures and requirements of the parties
  • workshops about the requirements and procedures for the designation and monitoring of conformity assesment bodies
  • joint training measures
  • observation of controls

All conformity assessment bodies designated by ZLG are obliged to participate in the confidence-building activities and in the national MRA information exchange. This is incorporated in the information exchange of the notified bodies in accordance with the Medical Devices Act (EK-Med).

If you should have precise questions regarding the work of the conformity assessment bodies, you can fill in the pre-prepared contact form. Please bear in mind that it could take some time to answer your query.

Conformity assessment bodiesRecognized testing laboratories for medical devices

A list of already designated recognised conformity assessment bodies can be found on our website.

flow chart detailling the designation procedure for conformity assessment bodies

Designation costs
In accordance with the Rules on Service Charges of the Land Nordrhein-Westfalen, a fee will be levied for designation, dependent on the size and workload of the procedure. Once the application documents have been received, an advance payment of € 1.000 per procedure will be charged, which will be deducted from the total cost.

Zentralstelle der Laender fuer Gesundheitsschutz bei Arzneimitteln und Medizinprodukten
Heinrich-Böll-Ring 10 · 53119 Bonn (Germany) · Phone: +49 228 97794-0 · Fax: +49 228 97794-44 · zlg(at)zlg.nrw.de