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,...
EUDAMED Registration – Act Now!
Registering your products in the EUDAMED database is a key step towards MDR compliance and gaining access to the European market. MDSS Consulting supports you with: Manual product registration Software-based mass registration Advisory and ongoing support Why act now?...
Attention to the REACH Regulation – Manufacturers, Importers, and Distributors of Medical Devices Are Affected Too!
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) introduce numerous new requirements for manufacturers, importers, and distributors of medical devices. However, it is crucial not to forget the obligations imposed by other applicable regulations, such...