medicines-medical devices-regulatory affairs
Last updated on 21 June 2026 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…
Date Guidance No About the guidance June 2026 MDCG 2021-5 rev.1 – Appendix Guidance on standardisation for medical devicesAppendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1 June 2026 MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
Last updated: 16 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory…
Last updated: 15 June 2026 For updates, click on the ‘+’ sign below. This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…
Date Title of guidance and link to document Type and levelof guidance About the guidance 12 Jun 2026 Forms FDA 3542a and FDA 3542: Questions and Answers Draft This guidance is intended to assist new drug application (NDA) applicantsand NDA…
Last updated: 11 June 2026 To view updates, click on the + sign below: TEAM NB Position Paper on IVDR Application and appropriate surveillance Transfer agreement Team-NB members adopted a template Agreement form related to the transfer of IVDR formal…
Last updated: 9 June 2026 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
Last updated: 8 June 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
Last updated: 28 May 2026 To view updates, click on the ‘+’ sign. Q&A on Periodic Safety Update Report (PSUR) Single-Assessment (PSUSA): Guidance document for assessors Revision 1 (17 Apr 2026) of the documents with the above title has been…
This post is an attempt to provide salient information on Case C-456/24 which concerns Halozyme Inc. vs the Supreme Administrative Court, Czech Republic. Specifically, it concerns the events leading up to the CJEU getting involved in the case as well…
Last updated: 11 May 2026 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…