A training dedicated to help manufacturers to clarify the MDR Technical Documentation requirements is planned on November 7th. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
Team-NB welcomes a new Canditate member from Poland, as the 5th member of the new category of NB in the designation process. From now on, the association has 42 members from 20 different countries
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
