November 2021
NCAs list to perform consultations
Information from HMA on which national competent authorities (NCAs) have [...]
October 2021
Questions and Answers on repackaging & relabelling activities under Article 16 Regulations.
The Questions and Answers has just been published as MDCG [...]
Team-NB Position Paper on “Artificial Intelligence”
During the General Assemble Meeting, Team-NB members approved a new [...]
Team-NB Position Paper on “Article 117 – NB Opinion template”
Team-NB members approved a new position paper prepared by the [...]
MDCG guidance
MDCG 2021-24 Guidance on classification of medical devices has been [...]
The Commission announced that the EUDAMED UDI/Devices registration and NBs & Certificates modules have been successfully deployed in the Production environment and are now available for use
The link to join the public part of the database [...]
September 2021
NBCG-Med meetings
All the Notified Bodies designated and the concerned stakeholders have [...]
Team-NB General Assembly meeting
Taking into consideration the travel restrictions, the Committee invited the [...]
Transition to the New EU CE Marking Regulation
Team-NB have been invited to speak at the event organised [...]
August 2021
Medtech Forum 2021 : Remote Audit Readiness
Following the forum that took place in April, here is [...]