2 October 2026
Overview of the September 2026 news not already reported: MDR/IVDR Reform progress under new Presidency, IMDRF September meeting presentations, and more.
22 September 2026
Which devices need UKCA Marking in 2026; will CE Marking will be recognized indefinitely in Great Britain; what are the available UK registration routes; and what manufacturers should plan for as the MHRA finalizes its new regulation.
2 September 2026
August 2026 regulatory roundup covering EUDAMED updates, PPWR FAQ changes, new MHRA fee consultation, new IMDRF guidance on SaMD PCCPs, and more.
7 August 2026
Overview of the July 2026 news not already reported: new MDCG guidance clarifying who is responsible for UDI assignment, updated UK and Swiss guidance, and more.
2 July 2026
Overview of the June 2026 news not already reported: Change in SS(C)P process for manufacturers, Guidance on the Packaging and Packaging Waste regulation, and more.
2 June 2026
Overview of the May 2026 news not already reported: AI Act postponement, new EUDAMED functionality, proposal to amend the EU-Monaco Agreement, and more.
19 May 2026
The MHRA published a draft of its new regulation, now open for comment on the WTO website. Click here to read what’s changing with UKCA Marking, the new International Reliance framework, and the proposed transition times.
4 May 2026
Find here an overview of the April news not already reported: Team-NB new and updated guidance, Article 10a decision flow chart, update on new common specifications, and more.
3 April 2026
March EU, UK, and Swiss regulatory updates not already individually reported: MDR/IVDR reform progress, MIR Form 7.3.1 update, swissdamed manual entry delay, UK clinical investigation guidance, and more.