Updated guidance was just published by the MDCG to better clarify the notion of Basic UDI-DI, its usage and when a UDI-DI requires changes. The…
Official MDR & IVDR Corrigendum published!
On May 3rd 2019, the Corrigendum of both Regulations was published in the Official Journal of the European Union. MDR Corrigendum IVDR Corrigendum Apart from…
MDCG on registration of ”legacy” devices
The second document related to EUDAMED was published today on the European Commission website. The MDCG discussed registration of a ”legacy” device, i.e. device with…
MDCG on registration of devices in EUDAMED (timelines)
In the most recently endorsed document, the MDCG addressed the issue of inconsistency between Article 123(3)(d) and 123(3)(e) of the MDR. These provisions foresee certain…
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 to help you comply with the General Safety and Performance…
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 that was so far subject to different interpretations. Second paragraph…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent study organized by the Team-NB concerning the 2018 and wished…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an internationally recognised medical devices nomenclature that will be free of…
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 117 of the Medical Devices Regulation (MDR) that requires intervention…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and…