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 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.

MHRA releases new 2026 guidance on clinical investigation submissions via IRAS. Key requirements, timelines, and implications for manufacturers.

The European Commission expands the list of Class IIb implantable devices exempt from individual technical documentation assessment under MDR Article 52(4).

New Team-NB position paper clarifies IVDR expectations for safety, risk assessment and performance evaluation of reagent devices used in combination.

The MHRA has released updated guidance for clinical investigations of medical devices in the UK, outlining new requirements for manufacturers, including application validation, safety reporting, UKCA/CE/CE UKNI considerations, and updated processes for studies in Great Britain and Northern Ireland. Medical device manufacturers must review these regulatory changes to maintain compliance, ensure timely clinical investigation approvals, and prepare robust technical documentation aligned with UK and EU regulatory frameworks.

MedTech Europe 's new practical guide to the European Medical Device Nomenclature (EMDN) provides key guidance for medical device manufacturers and IVDs. The correct assignment of EMDN codes is mandatory for registering devices with EUDAMED and for demonstrating compliance with the MDR and IVDR.

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 has released a report on technical documentation training in the context of MDR 2017/745, which is essential for medical device manufacturers. The data shows that only 50% of SMEs have submitted a technical dossier, while 54% of large companies have already updated at least half of their documentation. The report highlights the need for continued support for small and medium-sized enterprises.