The Council of the European Union agreed today to a Mandate for launch of negotiations with the European Parliament to delay MDR under urgent procedure.…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6 months. Next meeting of the MDCG is only planned for…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the Notified Bodies under the MDR and IVDR. As it is…
More MDCG guidance released!
The MDCG endorsed two new documents, which brings us to three MDCG guidance’s in the past day! 2020-01 Guidance on Clinical Evaluation (MDR) / Performance…
We have the 10th NB under the MDR!
This morning, the European Commission updated the NANDO website and announced the designation of another Notified Body (NB) under the MDR – (EU) 2017/745: DNV…
Risk Management
In view of the recently published ISO 14791:2019, our experts updated the already published MDlaw guidance document/template to assist you drawing a detailed Risk…
State-of-play of NB designations
The European Commission (EC) published a document on the state-of-play of designation process of Notified Bodies under the MDR and IVDR: 44 applications received for…
European Medical Device Nomenclature
The European Commission Unit dealing with medical devices – newly under the Directorate for Health and Food Safety (move from DG GROW to DG SANTE)…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and has the purpose to help medical device manufacturers and other…
IVDR: 3rd NB accredited
Today, the European Commission updated the NANDO database by adding another Notified Body accredited for the assessment of devices under the In Vitro Diagnostic Medical…