The Position Paper has been approved by a very large majority of voters. Team-NB PositionPaper-on-MDR_IVDR-Implementation V3

The Questions and Answers has just been published as MDCG 2021-26 document. MDCG_2021_26_Art16

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