The MDCG has just published useful Questions & Answers document, especially relevant for the Notified…
MDCG on registration of devices in EUDAMED (timelines)
In the most recently endorsed document, the MDCG addressed the issue of inconsistency between Article…
MDCG on registration of ”legacy” devices
The second document related to EUDAMED was published today on the European Commission website. The…
New MDlaw Checklist: Crucial tool to show compliance with Annex I MDR
New GSPR Checklist, now available in our MDlaw e-shop was carefully prepared by our experts…
MDCG: When pre-market consultation of expert panel is not required
MDCG (Medical Devices Coordination Group) endorsed a Document, where it further explains the Article 54(2)b…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent…
EMA Q&A on Article 117 of MDR: Medicines with medical device component
Last Friday, European Medicines Agency (EMA) published first guidance on the implementation of the Article…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding…
Combination products: MDCG provides guidance on UDI-related obligations
The MDCG endorsed a new guidance on the UDI-related obligations when it comes to medical…