The UK’s regulatory landscape for medical devices just took a major leap toward long-term certainty. On 16 February 2026, the MHRA released a statement of policy intent, initiating consultation on the indefinite recognition of EU CE-marked medical devices that comply with EU MDR and IVDR.
The consultation is open for seven weeks, from Monday 16 February to Friday 10 April 2026 — share your views!
Why this matters: For years, the medical device and diagnostic industry has looked toward the end of CE marking acceptance by 2030 with uncertainty. This move aims to remove regulatory uncertainty, ensuring that UK patients continue to have uninterrupted access to safe, high-quality medical technologies while reducing the duplicative burden on manufacturers.
Key Pillars of the February 2026 Proposal:
- Indefinite CE Recognition: Proposing to allow devices compliant with EU MDR/IVDR to remain on the GB market indefinitely (subject to consultation).
- International Reliance Routes: Strengthening pathways to recognize approvals from “Comparable Regulator Countries” (CRCs), including the USA (FDA), Australia (TGA), and Canada (Health Canada).
- Innovation-First Approach: By relying on trusted international partners for established products, the MHRA is freeing up internal resources to focus on high-risk, innovative, and AI-driven medical devices.
- Alignment with Life Sciences Vision: This policy supports the UK’s goal of becoming the most attractive global market for MedTech innovation by 2030.
What stays the same?
- UK Responsible Person (UKRP): Manufacturers based outside the UK still require a UKRP.
- Post-Market Surveillance (PMS): Strict adherence to the new UK PMS requirements (effective June 2025) remains mandatory.
- English Labelling: All devices must still meet GB-specific labelling and packaging requirements.
This is a pragmatic and welcome step for the sector. It balances patient safety with the commercial reality of global supply chains.
Now is the time to make your voice heard. The outcome of this consultation will shape the UK regulatory framework for years to come. If you are a manufacturer, importer, distributor, UK Responsible Person, or industry stakeholder, we strongly encourage you to actively participate and ensure your perspective is reflected in the final policy.
If you would like to discuss how this proposal may impact your UK strategy, CE-marked devices, or post-market obligations, contact us. Our team is closely monitoring developments and is ready to support you in navigating the evolving UK regulatory landscape.
