The MDCG endorsed a Position document – Guidance on content of the certificates, voluntary certificate…
NBs on Classification Rule 8 of the MDR
NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable…
MDCG guiding principles for issuing entities: Basic UDI-DI
MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities…
NEW eBOOKS: How will the new Regulations (MDR/IVDR) impact you?
We are happy to announce the below two new publications that were added to our…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under…
EC public reply to PIP fraud Petition
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…
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…