medicines-medical devices-regulatory affairs
Last updated on 8 July 2025 See history of updates below. This post is an attempt to provide an information resource for the Medical Devices Regulation (EU) 2017/745 (MDR). The information provided is by no means exhaustive or complete. Although…
Last updated: 27 June 2025 To view updates, click on the ‘+’ sign below. What is COMBINE? COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research. When did the COMBINE Project 1 –…
Last updated: 27 May 2025 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…
Last updated: 18 March 2024 See updates at the end of the post. On 27 April 2023, the Commission proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies…
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…