Newsletter
Regulatory Matters
Every two weeks we bring you the regulatory changes that touch your file, explained for a founder who is not a regulatory specialist, with what to do about each one and by when.
Issue 001 · 22 October 2026
Great Britain will keep accepting CE-marked devices
The UK regulator, the MHRA, confirmed the decision on 21 October, after a consultation that drew more than 1,000 responses. Legislation and a start date are still to come. Also in this issue: register your devices in EUDAMED before 28 November, four FDA cases from October, and eight dates to watch.
By Daren Wilson · Regulatory statements reviewed by Niko Mangold