UK and EU move to streamline medical device regulation amid ongoing reforms
Recent regulatory updates across the UK and EU signal efforts to improve efficiency, clarity and market access for medical device manufacturers, while maintaining safety standards.
In the EU, new rules under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) aim to address long-standing concerns about delays, inconsistent assessments and cost uncertainty. Standardised timelines for conformity assessments and clearer requirements for notified bodies are intended to make approval processes more predictable for manufacturers. At the same time, amendments to the EU AI Act will give manufacturers until August 2028 to meet requirements for high-risk AI systems. However, companies developing AI-enabled medical devices will still face overlapping compliance obligations under both the AI Act and MDR/IVDR frameworks.
In the UK, draft legislation published in 2026 proposes a major overhaul of the medical devices regime, introducing a new standalone framework aligned with international standards. Key measures include stronger safety and documentation requirements, updated classification systems, and the introduction of unique device identifiers.
The proposals also include an “international reliance” pathway, allowing UK regulators to draw on approvals from trusted countries such as the US, Canada and Australia to support faster market access. This has been welcomed by industry as a pragmatic route to reduce duplication and speed up access to new technologies.
Overall, the changes reflect a more pragmatic regulatory approach on both sides, aiming to reduce bottlenecks and support innovation while ensuring continued patient safety.
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