The association meeting is scheduled on October 9th.

Team-NB members adopted a transfer agreement specifying the terms of the transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/7461. Team-NB-PositionPaper-IVD-Transfer-Agreement-20240911

Team-NB representative present at the panel on attractiveness of the EU Landscape for International Medical Device Manufacturers. See photo  

Team-NB is participating at TEAM-PRRC third Annual Summit event in Malaga on October 17 &18  

Team-NB representatives present at the panel on regulatory developments for combined products. See photo      

Team-NB represented at Basel on September 3rd. More info: https://medtech-pharma.com/annual-conference/

The draft amendment to class D IVD common specifications has been published for feedback on the Commission's portal. The deadline is 16 September.   Ares(2024)5908185 Ares(2024)5908185-Annex

The Commission prepared a survey for healthcare professionals and professionals working in healthcare institutions to gather feedback on the potential extension of scope of Implementing Regulation (EU) 2021/2226. The survey is available in all EU languages until 11 October 2024.   https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024  

Publication of the Commission Implementing Decision on the renewal of the designation of the issuing entities for a period of five years from 27 June 2024 until 27 June 2029. OJ_2024-2120-ComImplDecision-UDI

The REGULATION (EU) 2024/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices is published   [...]