Becoming increasingly important also for the med tech sector in view of the technical advancement,…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified…
MDCG: When pre-market consultation of expert panel is not required
MDCG (Medical Devices Coordination Group) endorsed a Document, where it further explains the Article 54(2)b…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent…
EMA Q&A on Article 117 of MDR: Medicines with medical device component
Last Friday, European Medicines Agency (EMA) published first guidance on the implementation of the Article…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding…