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.