On the 5th of December 2018, the General Court (the Court) delivered a judgment (currently…
European Commission publishes NEW Information sheets
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)…
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.…
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…