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.

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.