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.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

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.