As of February 2, 2026, the landscape for medical device manufacturing has officially shifted. The FDA has fully implemented the Quality Manage...
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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...
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...
EU to become the first market again? Significant reduction of MDR/IVDR burdens ahead!
On December 16, 2025, the European Commission published a legislative proposal substantially revising the Regulations 2017/745 (MDR) and 2017/7...
Eudamed Registration by MDSS – Order Now!
MDSS can manage your EUDAMED registrations on your behalf. Building on decades of experience with national and European device databases, MDSS ...
EU Consultation: Uniform Application of Requirements for Notified Bodies – Have Your Say!
The European Commission has launched a public consultation aimed at improving the uniform application of requirements for Notified Bodies u...
MDSS by your side: Derogation Success Story
“On a duly justified request, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of whi...
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): W...
What is the Australian IDID?
Australia’s new UDID system is here…but what does it mean for your medical devices? This video gives you the essentials you need to know an...
