medicines-medical devices-regulatory affairs
Date Guidance No About the guidance 14 Feb 2023 MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023 This document aims to clarify important terms…
Last updated: 6 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 13-14 December 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 20 December 2022 See updates at the end of this post. Report and minutes from the CMDh meeting held on 8-10 November 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Guidance No About the guidance MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, Revision 1 – December…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published Version 1.0 of the recommendation paper on decentralised elements in clinical trials . The 33 page document was adopted by the Accelerate Clinical Trials in…
Last updated: 28 November 2022 See updates at the end of this post. Anonymisation of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) EMA has published the…
Last updated 25 October 2022 See list of updates at the end of the post. Recommendations on submission dates in 2023 for Applications of the MRP This document was produced by the Coordination Group (CMDh) in order to facilitate planning of…
Guidance No About the guidance MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6)…
The Rules Governing Medicinal Products in the European Union : Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Revision to Annex 1: Manufacture of Sterile Medicinal Product Volume 4 of “The rules…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timelycompliance with MDR requirements From 27 May 2024, the MDR will be fully applicable…