The Team-NB performed a new survey in December and collected the data on the designation process of Notified Bodies under the MDR. On the date…
NB express concerns on MDR application date
Team-NB and NB-MED issued a White paper on the occasion of 26 November 2018 – 1 year after the designation process of Notified Bodies under…
New judgment of the CJEU: Access to Documents on NB
On the 5th of December 2018, the General Court (the Court) delivered a judgment (currently only in French and Italian language) on access to documents…
European Commission publishes NEW Information sheets
The European Commission has published today 9 Factsheets related to the MDR and IVDR. The documents present main changes, new requirements, transition timeline and frequent…
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) under the MDR/IVDR at the date of 9 October 2018.…
Brexit and MDR: UK publishes two notices
Notice of 23 August: MDR, CE marking in “no-deal” scenario (after 29 March 2019) For a time-limited period, UK would continue to recognise the CE Mark…
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) under the MDR/IVDR at the date of 30 June 2018:…
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 applied for the designation under the MDR. So far, 65% of…
Joint Action on Market Surveillance of MD
The UK Medicines and Healthcare products Regulatory Agency and Chafea, executive agency of the European Commission have signed a Grant Agreement in order to reinforce market surveillance of…
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. As previously discussed on this blog, the submission of the application…