The European Commission (EC) published a document on the state-of-play of designation process of Notified…
European Medical Device Nomenclature
The European Commission Unit dealing with medical devices – newly under the Directorate for Health…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and…
IVDR: 3rd NB accredited
Today, the European Commission updated the NANDO database by adding another Notified Body accredited for…
MDCG Guidance timeline updated
Today, an updated version of the MDCG work progress was released, listing past and ongoing…
MDCG Guidance on MDR/IVDR device sampling + MDR Codes
The MDCG published two important guidance documents this afternoon. Firstly, an Explanatory note on MDR…
UDI issuing entities on Basic-UDI and UDI formats
The four accredited UDI issuing entities (which were designated by the Commission Implementing Decision of…
EUDAMED delayed!
The European Commission officially announced the delay of the EUDAMED database to May 2022: ”…
Timeline for future MDCG documents published!
Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined…
EMA Q&A Document on implementation of MDR and IVDR update released.
Questions and Answers document updated version has been released on 21.10.2019 by the European Medicines…
