Recently, twelve standards were added to the list of harmonized standards under the EU MDR (Regulation (EU) 2017/745). The list of standards, p...
UK MHRA Proposes Indefinite Recognition for CE-Marked Devices
The UK’s regulatory landscape for medical devices just took a major leap toward long-term certainty. On 16 February 2026, the MHRA released a...
The New Era of FDA Inspections
As of February 2, 2026, the landscape for medical device manufacturing has officially shifted. The FDA has fully implemented the Quality Manage...
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 ...
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...
