Date | Guidance No | About the guidance |
---|---|---|
7 Feb 2025 | MDCG 2019-6 rev.5 | Questions and answers: Requirements relating to notified bodies (February 2025) This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The issues covered by this document have been identified in the context of joint assessments, and the document may be updated from time to time as new issues are identified. the revision table is presented on page 2 of the updated document. |
Jan 2025 | MDCG 2025-3 | EMDN Version History |
Jan 2025 | MDCG 2025-2 | EMDN UPDATE SUBMISSIONS FROM 2024 PUBLIC CONSULTATION AND THE MDCG NOMENCLATURE WORKING GROUP |
Jan 2025 | MDCG 2025-1 | EMDN Ad hoc procedure form |
Jan 2025 | MDCG 2024-2 rev.1 | Procedures for the updates of the European Medical Device Nomenclature Revision 1 – January 2025 In this the first revision, the changes concern: Inserting table for ad hoc procedure aligning with newly published template form for submissions |
Jan 2025 | MDCG 2021-12 rev.1 | FAQ on the European Medical Device Nomenclature (EMDN) Revision 1 – January 2025 Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the functioning of the European database on medical devices (EUDAMED). Among its various uses, it will be utilised by manufacturers for the registration of medical devices in EUDAMED, where it will be associated to each Unique Device Identifier – Device Identifier (UDIDI1). In this the first revision, the changes are: -Restructuring of questions into clear categories – Addition of questions 7 – 24 |
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