Medical Devices – Changing Regulatory Landscape in the UK & EU

Medical Devices – Changing Regulatory Landscape in the UK & EU: Whitepaper Overview

Navigating the UK and EU medical device regulatory landscape is increasingly challenging due to evolving and diverging standards. While the EU continues to advance its MDR and IVDR frameworks and other regulations, the UK is establishing its own regulatory path through MHRA reforms post-Brexit.

Understanding these developments and their implications is crucial for manufacturers seeking market access in both regions. Efforts toward regulatory convergence and international recognition offer potential pathways to reduce complexity and enhance compliance across borders.

This Whitepaper Covers:

• Regulatory Developments in the UK and EU
• EU and UK Reforms and Their Cross-Market Impact
• The Path Forward for Medical Device Manufacturers

*This whitepaper was originally published on 15th April, 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

Authors

Fernanda Paro, Regulatory Compliance Specialist, Compliance & Risks

Fernanda is a Regulatory Compliance Specialist within the Global Regulatory Compliance Team, serving as the primary Subject Matter Expert (SME) for Medical Devices.

She specializes in monitoring and analyzing regulatory updates across various Latin American countries. Fernanda holds a Master’s Degree in International Trade Law with a focus on Medical Devices, Data Protection, and Cybersecurity.

As a qualified lawyer registered in both Brazil and Portugal, she brings extensive expertise in navigating complex regulatory landscapes to ensure compliance and strategic alignment.