The European Commission has adopted Regulation (EU) 2026/977 introducing new MDR and IVDR rules for notified body timelines, quotations, transparency and re-certification activities.

The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.

MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.

TEAM-NB releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.

Team NB explains when manufacturers can rely on non-clinical data under MDR Article 61(10) and highlights common compliance pitfalls.

Team-NB releases Version 4 guidance on MDR technical documentation. Key requirements, common pitfalls, and implications for medical device manufacturers.

MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

Notified bodies highlight key risks and proposals in the EU MDR/IVDR targeted revision, including clinical evidence, WET, and regulatory oversight.

The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.

Latest European Commission data shows MDR and IVDR application volumes, certification timelines, and submission quality based on the 18th Notified Body survey (October 2025 data).

Team-NB releases a position paper defining how manufacturers can transfer notified body surveillance for legacy devices under MDR Article 120, including key requirements, timelines, and responsibilities.

MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.

Team-NB warns that proposed MDR and IVDR revisions could reduce regulatory scrutiny and create unintended consequences for EU manufacturers, despite improvements in digitalisation and innovation pathways.

MHRA updates guidance on medical device regulation in Northern Ireland. Key impacts for manufacturers under EU MDR and IVDR.

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.