DIMDI - Certificates for Medical Devices

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Certificates for Medical Devices

The notified bodies certify the manufacturers that a medical device conforms to both the EU and German legal requirements. Since January 1st 2004, the German notified bodies enter the notifications on issued, restricted, suspended, withdrawn or refused certificates (according to § 18 Medical Devices Act, MPG) in the Medical Devices Information System.

The content of the certificates database is based on Annex 3 of the DIMDI-Verordnung. Only the competent notified bodies and competent authorities currently have access to this database.

The addresses, identification numbers and scope of the notified bodies in Germany and the EEA member countries as well as the notifying authorities can be found under: