This regulatory update summarises the Team-NB Position Paper adopted on 12 December 2025, which describes how IVD Notified Bodies will handle conformity assessments following the down-classification of SARS-CoV-2 in vitro diagnostic devices under Regulation (EU) 2017/746 (IVDR). The document reflects the IVD Expert Panel scientific advice published in January 2025 and the subsequent update of MDCG 2020-16 Revision 4, detailing classification changes, certification scenarios, and manufacturer obligations related to SARS-CoV-2 tests.

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.

The new version of the Team-NB Code of Conduct establishes principles of transparency, coherence and quality in the work of Notified Bodies operating under the MDR and IVDR regulations. The document presents clear criteria for audits, technical review, management of conflicts of interest, use of external experts and deadlines for responding to non-conformities.

The June 2025 report on the coverage of MDR and IVDR designation codes by notified bodies provides an updated view on the availability of designated bodies for specific categories of medical devices and in vitro diagnostic medical devices. It identifies critical areas with lower coverage, such as active implantable medical devices (codes MDA 0101 to MDA 0104) and devices originating from human tissues (MDS 1002), as well as IVDs for blood and tissue typing (codes IVR 0101 to IVR 0202). For medical device manufacturers seeking certification under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, analysis of these codes is essential to plan the submission of applications to notified bodies with adequate coverage.

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.