December 2021
Team-NB Position Paper on MDR/IVDR Implementation
The Position Paper has been approved by a very large [...]
November 2021
Team-NB representative invited to give NBs point of view at the “Forum Risk Management”
Medical Devices made of substances research and innovation opportunities for [...]
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 [...]