You will find below the updated document on the ongoing work of the MDCG and…
Council gives green light to launch negotiations on MDR delay + MDCG Guidance on NB audits during COVID-19
The Council of the European Union agreed today to a Mandate for launch of negotiations…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the…
More MDCG guidance released!
The MDCG endorsed two new documents, which brings us to three MDCG guidance’s in the…
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…
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…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and…
