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…
MDCG guidance on standardisation for medical devices
The MDCG document pursues to provide guidance on several features related to standards in the…
Standardisation request for the EU MDR & IVDR
The European Commission has notified today CEN and Cenelec of the Standardisation request in the…
IVDR Certification of Class D devices, Implementation Plan and MDR NB
The MDCG released an important Q&A for manufacturers of Class D devices and their certification…
Switzerland: precautionary measure ahead of 26 May 2021
In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland…
Language requirements & sanctions under the MDR: Belgium
The text of the Medical Device Regulation (MDR) will become directly applicable on the Union…