| Date | Guidance No | About the guidance |
|---|---|---|
| 10 Jan 2025 | MDCG 2024-7 rev.1 MDCG 2024-7 Annex | Preliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents) |
| 7 Jan 2025 | MDCG 2023-3 rev.2 | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025 This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations. The document is written for competent authorities, economic operators and other relevant parties. The revisions are detailed on page 3 of the document. |
Pharmavibes
medicines-medical devices-regulatory affairs