Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.

Regulation (EU) 2017/745 sets out the European regulatory framework for medical devices, covering market access, economic operators, clinical evaluation, vigilance, PMS, UDI and notified bodies.

The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.

The European Commission has published the third EO survey results on the availability of medical devices and IVDs on the EU market, with data status 31 October 2025.

The European Commission has published an unofficial consolidated version of the AI Act incorporating the Digital Omnibus amendments, providing an updated reference for manufacturers and other stakeholders.

Team-NB has published a position paper proposing measures to support micro and small medical device manufacturers under the MDR and IVDR, focusing on regulatory efficiency, structured dialogue, risk-based oversight and regulatory capability.

Swissmedic has published Version 6.0 of its Information Sheet – Procurement of Medical Devices in Healthcare Institutions, providing guidance on the procurement of medical devices and IVDs in Switzerland, including conformity documentation, certificate verification and the use of swissdamed.

A new legal opinion analyses the European Commission’s proposed MDR Article 50, highlighting potential impacts on notified bodies, SMEs, certification costs, and conformity assessment access.

The Australian TGA has updated its guidance to recognise UK Approved Bodies as comparable overseas regulators, potentially simplifying ARTG submissions for medical device and IVD manufacturers.

The MHRA has released new visual guidance on UK MDR 2002 conformity assessment routes for medical devices. Learn what Class I, IIa, IIb, III, AIMD, and custom-made device manufacturers need to know for UKCA compliance and GB market access.

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

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.

TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.

New MHRA guidance summarises UK conformity routes for all medical device classes. Essential for UKCA compliance and UK MDR planning.

Swissmedic’s review of Notified Body Opinions under MDR Article 117 reveals major gaps in documentation quality for drug–device combination products. Updated expectations now apply to ensure compliance with GSPRs.

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 new MDCG 2025-6 guide, published in June 2025, clarifies the joint application of the AI Act and the European MDR/IVDR regulations for medical devices and IVDs with artificial intelligence systems. The document addresses classification, risk management, life cycle, technical documentation and post-market monitoring. Smart MDR supports manufacturers in integrating these requirements into their quality management system and preparing for audits.

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.

Implementing Decision (EU) 2025/681 introduces six new harmonized standards under the Medical Devices Regulation (MDR), directly impacting manufacturers of single-use medical gloves, sterile devices and ambulance patient transport equipment. Compliance with these standards allows presumption of conformity with the essential requirements of the MDR, facilitating CE marking and access to the European market. Smart MDR supports manufacturers in reviewing technical documentation, assessing regulatory impact and adapting processes to the new European legislation.