The European Commission received only five preliminary assessment reports from the “designating authorities” by February 12, 2018.…
Survey by TEAM-NB on applications of Notified Bodies under MDR
As stated in the survey performed by Team-NB*, already 80% of the Team-NB members submitted their…
Implementing MDR: Focus on transition period by COCIR and CAMD
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…