Implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) Regulation has been published. More info: Health Technology Assessment - Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices
Team-NB members adopted a common paper aimed at describing in detail the pre-application and application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). Team-NB-PositionPaper-MDR-Certification-Process-Consensus-Document-20241218
Some high level data providing an overview on Team-NB Notified bodies members and their activities. Team-NB-byFewFacts-and-Numbers-Strategy-20241213
TEAM-NB set up a new date for the MDR technical documentation training for manufacturers on February 12th, 2025. MDR Technical Documentation Training for Manufacturers For registration, follow the link: ManufacturerTraining
You will find information on the endorsement of Multi Services Agreement template. Press Release-EURLs-TransitionToOperations-20241212
The Q&A is available on the Commission web site. Link : https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf
The press release on the new version 5 of the Team-NB Code of Conduct is presenting the main changes and the list of the signatories. PressRelease-CoC-20241204
More info in document : Team-NB-HighLevel-Strategy-PositionPaper-20241130
The press release is presenting the outcomes of the course and the progress of the manufacturers towards their transition to MDR thanks to responses of the attendants of November 6th session. Info on the last MDR training session : PressRelease-Training-for-MD-manufacturers-20241126
This questionnaire was prepared in accordance with MDGG 2022-14 requests. It is to be understood in the context of MDR and IVDR Regulations as well as MDCG guidance (MDSW). Specific requirements of the AI Regulation 2024/1689 have not been considered and will be part of a comprehensive revision which is to follow. However, it should [...]
