Regulatory guidance
Preliminary re-assessment review (PRAR) form template (MDR)
Published May 1, 2024
Reference
MDCG 2024-6
Source
MDCG
Topic
Notified bodies
Published
May 1, 2024
Languages
EN
© European Union — European Commission, DG SANTE. Reuse under CC BY 4.0.
Questions and answers: Requirements relating to notified bodies
Published Feb 1, 2025
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)
Published Jan 1, 2025
Annex to Application Form & PAR Template MDR (List of documents)
Published Jan 1, 2025
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
Published Jan 1, 2025