medicines-medical devices-regulatory affairs
Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…
Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…
Lost updated: 14 November 2023 See updates at the end of this post. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product This list has been updated and you can download the latest version…
Last updated: 19 October 2023 See updates at the end of the post. Clinical Trials Regulation (EU) No 536/2014 Questions and Answers The Q & A document has been updated to Version 6.6 of September 2023. You can view it…
Last updated on 26 September 2023 See updates at the end of the post. Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation The European Commission recently published guidance on the transition…
Last updated: 27 July 2023 See updates at the end of the post. Draft Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle This reflection paper provides considerations on the use of AI and Machine…
Date Guidance No About the guidance 30 Jun 2023 Add 1 – MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Addendum…
Last updated: 28 June 2023 See updates at the end of the post. Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations Revision 2 (of 27 June 2023) of the above…
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…