On December 16, 2025, the European Commission published a legislative proposal substantially revising the Regulations 2017/745 (MDR) and 2017/7...
Your Voice Matters: Help Shape the Future of EU Medical Device & IVD Regulations!
The European Commission has opened a consultation on the targeted revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic ...
Change of classification Reduced risk of SARS-CoV-2
The European Commission made an announcement for manufacturers of SARS-CoV-2 tests, after scientific advice has been received from the IVD expert pane...
Article 10a MDR/IVDR: provisions apply from 10 January 2025!
The European Commission’s newly released Q&A on Article 10a of the MDR and IVDR (Medical Device Regulation and In Vitro Diagnostic Regulation) i...
New documents published by the European Commission!
We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sect...
