The Council of the European Union agreed today to a Mandate for launch of negotiations…
Pre-market clinical evaluation consultation procedure: Update to MDCG guidance
The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts…
EC Proposal to delay MDR: which provisions are affected?
The European Commission proposal for the MDR delay is now officially published and accessible through:…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6…
MDR delayed for 12 months due to COVID-19?
The European Commission is proposing to delay the MDR for 12 months to fight the…
We have the 12th NB under the MDR!
Over the weekend, the European Commission updated the NANDO website and announced the designation of…
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…
Guidance on significant change for legacy devices (MDR)
All manufacturers making use of the grace period as per the Article 120 (3) of…
MDCG Joint Implementation/preparedness plan on MDR
The MDCG just publicly announced that the Actor registration will be available in EUDAMED by…