Titanium Dioxide and MDR/IVDR: Clarification Following the CJEU Judgment – What Manufacturers Need to Know
With its judgment of 1 August 2025, the Court of Justice of the European Union dismissed the appeals against the judgment of the General Court of 23 November 2022. As a result, the partial annulment of Delegated Regulation (EU) 2020/217 concerning the harmonised...
Deadline for EUDAMED Registration Is Here!!! … The clock is ticking!
The European Commission has taken a decisive step toward implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR): With the publication in the Official Journal of the European Union on 27 November 2025, the full functionality of the...
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,...