UK Medical Device Regulation

Maytal Attending EBME Expo 2025 in Coventry

Navigating Dual Certification: How to Stay Compliant Across the UK and EU

As we enter 2026, the post-Brexit regulatory landscape for medical devices continues to evolve, presenting both challenges and opportunities for manufacturers targeting the UK (Great Britain) and EU markets.

Stay Compliant with EN ISO 10993-1:2025 Updates

The publication of EN ISO 10993-1:2025 represents a key milestone for all medical device manufacturers who will be required, during 2026, to assess the need to update their biological evaluation documentation. Maytal can support you in a comprehensive and structured manner to address this regulatory update efficiently and without slowing down your ongoing projects