The link to join the public part of the database is: https://ec.europa.eu/tools/eudamed/#/screen/home

All the Notified Bodies designated and the concerned stakeholders have been invited to different meetings taking place on October 5 to 7th. These meetings will take place remotely

Taking into consideration the travel restrictions, the Committee invited the members to a remote  General Assembly meeting of the association wscheduled on October 6th

Team-NB have been invited to speak at the event organised at Tel Aviv on December 21st. See programm joined.

Following the forum that took place in April, here is a link to the article published in the MedTech Strategist Market Pathways journal. https://www.mystrategist.com/market-pathways/article/remote_audit_readiness_leaders_share_key_learnings_.html

Team-NB members approved a new position paper prepared by an internal task force of 12 participants and entitled: “Team-NB Position Paper on a risk-based approach for medical devices exempted from an implant card and information to be supplied tothe patient with an implanted device per Article 18.3” Team-NB Position Paper Implant Card

Here is the summary of decisions taken : • the UDI/Device module will be released in Production in September 2021. Voluntary use is possible and workable. • the NBs and Certificates module will be released in Production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in [...]

The aims are to help the auditors to assess in a remote way againt MDR and to harmonise practices. It appears that the practices are already reasonably harmonised; only minor differences. A second training is already planned end of August.

All the information and contact are available on https://app.gignow.com/ey/job_postings/6a654c78d8bb442897d756e9d832b215.

Team-NB representative operates a session on the implementation of the new IVD regulation organised by SIDIV for its members