A análise dos dados MDR e IVDR com base na resposta completa dos Notified Bodies é um diferencial estratégico para fabricantes de dispositivos médicos na UE. Ao integrar essas informações ao seu planeamento regulamentar, a sua empresa pode antecipar riscos, otimizar prazos e garantir conformidade com as exigências europeias de forma mais eficiente.

Team-NB 's official position paper on the implementation of the AI Act offers key guidance for manufacturers of medical devices with artificial intelligence. The document analyzes the integration between the AI Regulation and the requirements already established by the MDR and IVDR, underlining the classification of devices with AI as high-risk systems.

The new version of Team NB's good practice guide for submitting technical documentation under Regulation (EU) 2017/745 (MDR) provides clear guidance for medical device manufacturers. The document addresses the structuring of dossiers, the consistency of data, common mistakes to avoid and the importance of effective communication with Notified Bodies.

Team-NB, the European association of Notified Bodies, has reinforced the importance of issuing certificates with conditions under the European Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). This approach allows innovative or orphan medical devices to obtain certification under specific conditions, such as more frequent post-market assessments, restriction of use to certain population groups or marketing limited to specialized medical institutions. Team-NB encourages Notified Bodies to apply this strategy to balance innovation and patient safety, ensuring faster access to new medical technologies.

Revision 5 of MDCG 2019-6 presents important updates on the requirements for Notified Bodies under the MDR and IVDR, reinforcing regulatory compliance and promoting harmonisation within the European Union. It includes clarifications on impartiality and independence, as well as specifications on consultancy, training and experience of personnel involved in conformity assessment.