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...
EU Standards Update
Recently, several standards were added to the list of harmonized European standards for medical devices and IVDs. The European Union (EU) has a long h...
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The European Commission has released a draft guidance and reporting template to support the upcoming requirements of the EU AI Act.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...
Major Changes to UK MHRA Medical Device Registration Fees
Call to Action in the UK database: Save money by deactivating devices that are no longer placed on the UK market. The UK’s Medicines and ...
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...
