Manufacturers of implantable medical devices: new MDCG guidance on implant card!
The MDCG has released a very important guidance on the ”device type” to be shown…
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IVDR Joint Implementation Plan: Priority actions
Following the challenges encountered by the whole sector in the implementation of the IVDR, the Medical Device Coordination…
MDCG on EMDN & IMDRF (UDI)
The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down…
3 days under the MDR & new MDCG Position Paper on UDI
26 of May 2021 was probably the most important day of 2021 for the medical…
Clinical investigation application/notification under MDR: MDCG provides important templates
The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the…
UDI Helpdesk ready for use!
The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in…
Standardisation request for the EU MDR & IVDR: update
The European Commission has informed that the Standardisation request from 14.4.2021 in support of Regulations…
EMDN is online!
The European Commission has released and opened for consultation the first (English) version of the…
Overview of published documents Jan-April 2021
To improve MDlaw experience and to keep you informed of all the relevant publications of…
Update to MDCG UDI Guidance & Minutes from the recent MDCG meetings released!
Guidance on BASIC UDI-DI and changes to UDI-DI The new revision of the MDCG guidance…
Clinical investigations under MDR: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document aimed at assisting sponsors by clarifying…
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