The European Commission (EC) published a public letter to the PIP Implants World Victims Association…
New UK guidance: ”no deal” scenario
The UK Government issued a new guidance in the beginning of the year on how…
TEAM-NB Survey on NB Designation process
The Team-NB performed a new survey in December and collected the data on the designation…
NB express concerns on MDR application date
Team-NB and NB-MED issued a White paper on the occasion of 26 November 2018 -…
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…
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
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…