The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the signed Mutual Recognition Agreement (MRA) between Switzerland and the European…
UDI Helpdesk ready for use!
The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in implementing the UDI-related requirements of the MDR and IVDR and…
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 (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] has been accepted…
EMDN is online!
The European Commission has released and opened for consultation the first (English) version of the European Medical Device Nomenclature (EMDN). This is an important step…
Overview of published documents Jan-April 2021
To improve MDlaw experience and to keep you informed of all the relevant publications of the first four months of 2021, we present the below…
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 on the Unique Device Identification (UDI) system for medical devices…
Clinical investigations under MDR: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document aimed at assisting sponsors by clarifying certain aspects of clinical investigation of medical devices within the…
MDCG guidance on standardisation for medical devices
The MDCG document pursues to provide guidance on several features related to standards in the medical devices industry supporting the requirements set down in the…
Standardisation request for the EU MDR & IVDR
The European Commission has notified today CEN and Cenelec of the Standardisation request in the Implementing Decision C(2021) 2406, which will serve as the basis…