The European Commission has published a new EUDAMED User Guide – UDI Devices (Production v2.22.0 – 2026), providing comprehensive and...
New MIR form – mandatory as from 1st May 2026
The European Commission has confirmed that the updated Manufacturer Incident Report (MIR) form version 7.3.1 will become mandatory from 1st May...
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 ...
Saturday Night Thoughts: A Few Minutes on MDR/IVDR
Structured Dialogue, supports early and transparent exchanges between manufacturers and notified bodies to set expectations and reduce incomple...
