We are happy to announce the below two new publications that were added to our MDlaw e-shop! MDR eBOOK IVDR eBOOK In approximately 200 pages,…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on Medical Devices in the NANDO database! The first NB…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under the IVDR and currently: From 20 Team-NB notified bodies…
EC public reply to PIP fraud Petition
The European Commission (EC) published a public letter to the PIP Implants World Victims Association and rejected the petition to claim the financial compensation at…
New UK guidance: ”no deal” scenario
The UK Government issued a new guidance in the beginning of the year on how a ”no deal” Brexit will affect the regulatory framework of…
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…