IVDR

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…

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…

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…

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…

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…

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…

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…

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…

The MDCG released an important Q&A for manufacturers of Class D devices and their certification during the transition period – until 26 May 2022 or…

In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland and the European Union, the Swiss Federal Office of Public…