The European Commission announced the 11th Notified Body designated under the Regulation (EU) 2017/745: National…
We have the 10th NB under the MDR!
This morning, the European Commission updated the NANDO website and announced the designation of another…
Risk Management
In view of the recently published ISO 14791:2019, our experts updated the already published…
Annex XVI MDCG sub-group: Become an observer
Under the EU MDR and IVDR, the MDCG (Medical Device Coordination Group) provides advice and…
State-of-play of NB designations
The European Commission (EC) published a document on the state-of-play of designation process of Notified…
European Medical Device Nomenclature
The European Commission Unit dealing with medical devices – newly under the Directorate for Health…
Croatian Presidency of the EU
Croatia has started presiding the Council of the European Union on the 1st of January…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and…
MEDCERT designated under the MDR (9th NB)
With the below German Notified Body, designated for the assessment of devices under the MDR…
MDCG Guidance timeline updated
Today, an updated version of the MDCG work progress was released, listing past and ongoing…