Today, COCIR* issued a Position paper on the implementation of the future Regulation on Medical…
EU Court decides: Software as MD
On 7 December 2017, the Court of Justice of the European Union rendered a judgment in…
1st Commission Implementing Regulation published!
After the closing of public consultations, the first Commission Implementing Regulation under MDR and IVDR…
New MDR Implementation Tools available in our E-shop !
The below two documents will help manufacturers better understand the MDR timeline, how to comply…
The Commission publishes NEW list of harmonised standards
The European Commission published an updated list of CEN/ Cenelec harmonised standards in the framework of the…
Applications to be designated as NB under MDR/IVDR open from 26 November
6 months after entering into force of the new legislation, the European Commission issued a…
Brexit contingency plan: No-deal scenario
The UK Secretary of State for Health and Social Care sent a letter to all…
MDCG Working Groups: Tasks, Membership, Meetings
The Terms of reference of the following MDCG Working Groups were recently published: MDCG Working…
The EC requests guidelines on phthalates in certain medical devices
The European Commission has requested the Scientific committee* to provide guidelines on the benefit risk-assessment of…
NEW documents on UDI endorsed by the MDCG
The Medical Devices Coordination Group (MDCG) endorsed 4 new documents related to UDI. 1. UDI…