Designation of notified bodies

Designation of notified bodies

Application for the designation of conformity assessment bodies

Designation as a notified body requires extensive joint evaluation by the authorities of three EU Member States and final approval by the MDCG body formed by the Commission and other Member States.

Before submitting the application, we advise contacting [email protected] already at the application drafting stage. The fixed-format application must be prepared using the form published on the EU Commission’s website. The application process is described in the NBOG’s Best Practice Guide 2017-1 published by the EU Commission: Designation and notification of conformity assessment bodies.

Further information on the requirements imposed on notified bodies:

MD Regulation, Chapter IV

IVD Regulation, Chapter IV

Commission website

Guidance by the Medical Device Coordination Group (MDCG)