During the General Assemble Meeting, Team-NB members approved a new position paper prepared by the “AI&Mobile-Ap-TF” internal task force with the intention to express their opinion and concerns regarding the upcoming regulations. Team-NB-PositionPaper-Artificial-Intelligence
Team-NB members approved a new position paper prepared by the “Article 117” internal task force during the General Assemble Meeting with the intention to provide a template for the opinion of the Notified Body. Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1
MDCG 2021-24 Guidance on classification of medical devices has been published. Here is the link https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
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 [...]
