Becoming increasingly important also for the med tech sector in view of the technical advancement, cybersecurity aims at incorporating measures, both technical and organisational, that…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing of single-use medical devices (rules and common specifications) until 20th…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC. The main clarifications focused on qualification of the…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the Annex listing the following four issuing entities designated to operate…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR…
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 that was so far subject to different interpretations. Second paragraph…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent study organized by the Team-NB concerning the 2018 and wished…
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 117 of the Medical Devices Regulation (MDR) that requires intervention…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an internationally recognised medical devices nomenclature that will be free of…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and…