The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR…
New expert group under MDR
A new expert subgroup of the MDCG was established to cover Annex XVI products; therefore issues with products without an intended medical purpose but falling…
Clinical Evaluation Report: New MDR implementation tool
The results of clinical evaluation and clinical evidence on which it is based shall be documented in a clinical evaluation report (CER), which shall support…
MDCG Guidance on Basic UDI-DI
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 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…
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…
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…