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...
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...
Help Shape the Future of AI Regulation: Feedback Needed on Serious Incident Reporting
The European Commission has released a draft guidance and reporting template to support the upcoming requirements of the EU AI Act. These docum...
RAPS 2025 – What We Learned About AI, Submissions, and Where Regulatory Heads Next
We are thankful for the opportunity to engage with a large number of attendees at the RAPS Convergence — especially our clients who stopped b...
Eudamed Registrations are Coming — We Can Do the Job for You!
The Eudamed actor and device registrations will become mandatory next year (May?)*. Failing to comply could jeopardize device conformity and di...
