The UK's MHRA Opens Public Consultation on Indefinite CE Mark Recognition of Medical Devices and IVDs

The consultation aims to provide long‑term regulatory certainty and mitigate supply disruption, given that around 90% of devices on the GB market currently rely on CE marking (labels signifying that a device has been approved for patient use).

Proposal 1: Six‑Month Extension of Transitional Arrangements

Proposal 1 would extend the current GB transitional arrangements for devices that comply with the EU Medical Device Directive ("EU MDD"), aligning them with the EU Medical Devices Regulation ("EU MDR") transition. This would allow EU MDD‑compliant devices to continue being placed on the GB market until 31 December 2028 (instead of 30 June 2028), with potential for further alignment should EU timelines be extended.

Proposal 2: Indefinite CE Recognition for EU MDR and EU IVDR Devices

Proposal 2—expected to be welcomed by businesses operating in both GB and the EU—would provide indefinite recognition in GB for CE‑marked devices that comply with the EU MDR or the EU In Vitro Diagnostic Medical Devices Regulation ("EU IVDR"). Under this approach, CE‑marked devices could continue to be placed on the GB market indefinitely without additional regulatory steps. The MHRA is consulting on whether this indefinite recognition should apply to all CE‑marked devices or only to those that fall into the same or a lower risk class in GB compared with EU rules.

Proposal 3: International Reliance Route for Higher Risk Devices in GB

If Proposal 2 (indefinite CE recognition) is limited to devices in the same or a lower risk class, Proposal 3 would introduce an international reliance route for devices classified at higher risk in GB. Under this route, CE‑marked devices are not automatically accepted. Instead, while the MHRA (and approved bodies) would give significant weight to EU MDR/IVDR assessments, it would still conduct its own review and remain responsible for the market‑access decision.

Devices completing this process would receive a certificate of international reliance, valid for the same period as the relevant EU certificate. This route is not available for devices relying on EU self‑declaration that would fall into a higher GB risk class, as such devices have not undergone conformity assessment by an EU notified body and therefore do not hold an EU MDR or IVDR certificate. In practice, self‑declared Class I devices that would be classified as Class IIa in GB, and self‑declared Class A IVDs that fall into a higher GB risk class, would not qualify for the international reliance route and therefore must undergo UKCA conformity assessment to access the GB market.

The consultation closes on 10 April 2026, and it remains to be seen how its outcome will shape the medical devices and IVDs framework in GB.