The Team-NB members welcome the Commission proposal for amending Regulations as regards the transitional provisions for MDs and IVDs. The adoption of this proposal by European Parliament and Council will allow safe medical devices to remain available to patients and healthcare professionals. Team-NB members remain fully involved in all necessary activities with EU Authorities and [...]
The Commission proposal and related press material and factsheet are available on the Commission webpage.
To date the list of Team-NB member organisations is 34 from 17 Member States. TEAM-NB-Member-List-38
Team-NB welcomes a new Canditate member from Sweden, as the 1st member of the new category of NB in the designation process. From now on, the association has 33 members from 19 different countries
The awaited Guidance on Periodic Safety Upadate Report according MDR is available on the EU website MDCG-2022-21-PSUR.pdf
This position paper was prepared by the “AI & mobile app.” task force which include 16 representatives of the members. It was endorsed by electronic mechanism by a vast majority of members. The paper is underlying the importance of an update of the processes & personnel competence to align with the AI requirements, but not [...]
Team-NB welcomes a new member from Finland. From now on, the association has 32 members from 19 different countries
The summit gathered representatives from different parties - Commission, NBs, ARs, Manufacturers, consultants, lawyers - from more than 10 European countries, UK and US to exchange on PRRC. photo-PRRC.jpg
The members meeting in general assembly gave their agreement in principle on the draft position paper. A vote will take place to endorse it when the document is finalised after taking into account feedback from Commission and NBO.
This position paper was prepared by the Mirror-MDCG-Clinical Working group which include representatives of 11 NBs. It was circulated through CIRCABC to all NBs. It has been endorsed during the Team-NB general assembly meeting. Team-NB-PositionPaper-Off-LabelUse-V1-20221005.docx
