EUDAMED user guide – UDI Devices
The European Commission has published a new EUDAMED User Guide – UDI Devices (Production v2.22.0 – 2026), providing comprehensive and updated guidance on device registration and UDI data management under the MDR and IVDR. The guide outlines the key responsibilities...
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...