Team-NB Position Paper on MDR/IVDR Implementation
The Position Paper has been approved by a very large majority of voters. Team-NB PositionPaper-on-MDR_IVDR-Implementation V3
The Position Paper has been approved by a very large majority of voters. Team-NB PositionPaper-on-MDR_IVDR-Implementation V3
Medical Devices made of substances research and innovation opportunities for a sustainable healthProgramma-DispositiviMedici-ENG
Information from HMA on which national competent authorities (NCAs) have the capabilities to perform drug-device combination product consultations. See the link on HMA website: https://www.hma.eu/57.html
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