medicines-medical devices-regulatory affairs
What is the OPEN framework? The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities). Brief history of the OPEN framework Date Event Dec…
Last updated: 20 January 2026 To view updates, click on the ‘+’ sign below: On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective…
Date Guidance No About the guidance 19 Dec 2025 MDCG 2025–10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025) Unless otherwise stated, this guidance is applicable to all medical devices (MDs) and in…
Last updated: 18 December 2025 To view updates, click on the ‘+’ sign below. Highlights from the Clinical Trials Coordination Group (CTCG) plenary meeting On 3–4 November 2025, CTCG met at EMA to discuss initiatives aimed at streamlining clinical trial…
Date Title of guidance and link to document Type and levelof guidance About the guidance 17 Dec 2025 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Medical Devices) Further reading:FDA finalizes real-world evidence guidance for device sponsors,…
Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration between…
Last updated: 4 December 2025 To view updates, click on the ‘+’ sign below. The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the…
On 27 November 2025, a large number of National Competent Authorities (NCAs) and Ethics Committees committed to test a coordinated fast-track approach for evaluating multinational clinical trials. About the FAST-EU (Facilitating and Accelerating Strategic Trials) initiative When is the FAST-EU…
The European Commission has published new and updated guidance documents in Volume 10 of “The Rules Governing Medicinal Products in the European Union”, which applies to clinical trials under the Clinical Trials Regulation (EU) No 536 These updates, published on…
Last updated: 29 November 2025 See history of updates below This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign…
The MHRA has published a position paper which outlines the current approach by UK regulators and partners to design a forward-looking framework that meets the needs of patients with rare diseases, while ensuring robust evidence generation Furter detailed information is…
Last updated: 18 November 2025 To view updates, click on the ‘+’ sign below Updated PLM Portal eAF Release notes now available An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF…