Brexit Aftermath: The UK Eases Requirements for Clinical Investigations
In the recently updated guidance issued by the MHRA (Medicines and Healthcare products Regulatory Agency) — „Clinical investigations of medical devices – guidance for manufacturers“ (October 2025) — a noteworthy passage appears: „For studies in Great Britain only,...
Tips & Tricks for the EUDAMED Database – How Authorised Representatives Can Update Their Information and Competent Authority
If you work as an Authorised Representative (AR), you know the challenge: data changes, contact persons switch – and sometimes the competent authority needs to be updated. It sounds simple, but it’s only straightforward if you know the right way. In EUDAMED,...