Formulaire

Medical Device Declaration (DM Class I) Custom or Assembled (Form)

Allows a manufacturer to declare custom-made or assembled medical devices (Class I MDs) to ANSM pursuant to section R. 5211-65-1 of the Public Health Code. This approach is addressed to manufacturers with their registered office in France who place a medical device for the first time on the French market or in the European Union.

Replaces Cerfa No. 10852*05, which is no longer in force.

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    Émetteur du formulaire administratif : Ministry of Health

    Verified 14 May 2024 - Directorate for Legal and Administrative Information (Prime Minister)