medicines-medical devices-regulatory affairs
AI Airlock Background The AI Airlock was established to proactively investigate the regulatory challenges of AI as a Medical Device. Working with key partners during the pilot phases, the programme is working towards key project outputs including an improved regulatory…
Last updated: 13 September 2026 To view updates, click on the ‘+’ sign below. What are combined studies? Combined studies can be understood as studies that involve: What is COMBINE initiative? COMBINE is one of the initiatives highlighted in the Draghi…
Date Event Further information 16 Dec 2025 The EU commission published a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices The details of the Commission Proposal are discussed in this post1. 1 July 2026…
Last updated: 27 July 2026 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…
Last updated on 29 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…
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…
Last updated: 6 May 2026 To view updates, click on the ‘+’ sign below. The EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). EMA launched this pilot on 28 April 2026.…
Medical Devices (MD) registration When will the registration of Medical devices and procedure packs in Swissdamed become mandatory and replace the notification obligation and is there a transition period? The registration of devices, systems, and procedure packs according to Art.…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
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…