This PP has been prepared by all the Team-NB IVD active members and approved by all of the IVD NBs voters. Team-NB PositionPaper-BPG-IVDR-V1-20230225.docx
The Team-NB members are happy to learn that on 16th February 2023, European Parliament has voted with overwhelming majority to accept it. The formal adoption and subsequent publication in the Official Journal is now expected soon. The proposal will allow safe medical devices to remain available to patients and healthcare professionals. Team-NB members remain fully [...]
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
