Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten

Bodies

Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746

The Commission publishes the list of notified bodies according to Article 43 of Regulation (EU) 2017/745 and Article 39 of Regulation (EU) 2017/746, including the conformity assessment activities and the types of devices they are authorised to assess. The notifications are published in NANDO (New Approach Notified and Designated Organisations) after the German Designating Authority ZLG has designated the conformity assessment bodies in accordance with Article 42 MDR or Article 38 IVDR as applicable. In accordance with MDR Article 42 Paragraph 11 resp. IVDR Article 39 Paragraph 11, the designation issued by the ZLG becomes valid the day after the notification is published in NANDO.

Thus, the following list of bodies notified by the ZLG under Regulations (EU) 2017/745 and (EU) 2017/746 is purely informative.

Notified Bodies under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR)

List of Notified Bodies under Regulation (EU) 2017/745 – MDRinternal Link
List of Notified Bodies under Regulation (EU) 2017/746 – IVDRinternal Link

List of all European Notified Bodies (NANDO)

List of all European Notified Bodies

external Link

Notified Bodies under § 15 of the German Medical Devices Act

In accordance with § 15 (4) of the German Medical Devices Act, current information on the scope of designations as well as the identification numbers of German Notified Bodies in the area of medical devices are published on the website of ZLG as the German Designating Authority in that area. This information as issued by ZLG is authoritative and reflects the current status of designations. Information on the status and scope of designations on the website of the European Commission’s NANDO (see above) may deviate. As indicated also on the website of NANDO, the data given there are for information only, since designation and notification of conformity assessment bodies are in the responsibility of the Member States. Please do not hesitate to contact the ZLG in case of questions.

Notified Bodies under § 15 German Medical Devices Act

List of Notified Bodies – Directive 90/385/EEC on active implantable medical devices (status as of 25.05.2021)internal Link
List of Notified Bodies – Directive 93/42/EEC on medical devices (status as of 25.05.2021)internal Link
List of Notified Bodies – Directive 98/79/EC on in vitro diagnostic medical devices (status as of 25.05.2022)internal Link
List of identification numbers of Notified Bodies under § 15 Medical Devices ActPDF
List of all European Notified Bodies by identification numberexternal Link