The European Commission has published today 9 Factsheets related to the MDR and IVDR. The…
Update on received NB Applications by the EC
The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs)…
Brexit and MDR: UK publishes two notices
Notice of 23 August: MDR, CE marking in “no-deal” scenario (after 29 March 2019) For…
European Commission has received 28 applications from NBs
The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs)…
Team-NB: 65% of Members submitted applications to be designated under the MDR
The Team-NB conducted a second survey this year to establish the number of Notified Bodies that…
Joint Action on Market Surveillance of MD
The UK Medicines and Healthcare products Regulatory Agency and Chafea, executive agency of the European Commission…
Only 5 NB applied under MDR by mid-February
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…