UK Confirms Indefinite Recognition of CE-Marked Devices

The UK will keep accepting CE-marked medical devices on the Great Britain market indefinitely, MHRA confirmed on 21 October 2026 — closing off, for now, a question that has hung over device manufacturers' UK market-access planning since the post-Brexit transitional arrangements were first set. The decision follows a targeted consultation that drew more than 1,000 responses and applies to devices certified under the current EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Why this question needed answering

Since Brexit, Great Britain has relied on a series of transitional arrangements to let CE-marked devices — certified under EU rules, not the UK's own UKCA regime — continue reaching patients and providers without every manufacturer first securing a separate UK conformity assessment. Those arrangements always carried an expiry problem: a fixed future date after which CE-marked devices would, in principle, need a UKCA mark to stay on the market. With more than 90% of devices registered for use in Great Britain currently CE-marked, and the UK's own conformity assessment capacity still comparatively limited, a hard cut-off date was a standing source of planning risk for manufacturers and a supply risk for the NHS. MHRA opened a targeted consultation on 16 February 2026 to test three options: extending transitional arrangements for devices still certified under the older EU Medical Devices Directive (MDD), indefinite recognition for devices certified under the newer MDR and IVDR, and a possible new route recognising approvals from other trusted overseas regulators. It closed 10 April 2026 with more than 1,000 responses.

What was decided

The government's answer, as MHRA announced it on 21 October 2026, is indefinite recognition — not a later fixed date, but no fixed date at all — for devices and IVDs certified under the current EU MDR and IVDR. Manufacturers placing CE-marked MDR- or IVDR-compliant devices on the Great Britain market do not face a looming deadline by which they must additionally obtain a UKCA mark to keep selling. The UKCA mark itself is unaffected as a standing option: manufacturers who want the UK's own conformity mark, whether for commercial reasons or to reduce reliance on EU-based notified bodies, can still pursue it. What the decision changes is the absence of compulsion. MHRA frames the decision as paired with continued oversight rather than a step back from it, saying it continues to regulate all devices on the UK market regardless of which mark they carry, and that it has strengthened its post-market surveillance activity.

What is excluded

The indefinite recognition is specifically scoped to devices certified under the current EU framework — the MDR and IVDR, which themselves only fully phased in across the EU in recent years. Devices still placed on the market under the older EU Medical Devices Directive (MDD) or In Vitro Diagnostic Medical Devices Directive (IVDD) — the pre-MDR regime, which many legacy devices still rely on under the EU's own extended transitional provisions — are not covered by this announcement and remain subject to the transitional timetable the UK government had already set for them. Manufacturers with devices still certified under the older directives should not read this decision as extending their own runway; the relevant question for them is unchanged by today's announcement.

What this means operationally

• MDR/IVDR-certified devices: no new action is required to keep selling into Great Britain on a CE mark; the open question manufacturers have been planning around — a future reliance cut-off — is now closed.
• MDD/IVDD-certified legacy devices: confirm current status against the transitional timetable already published; this announcement does not change it, and a device still on the older directive should not be assumed to have gained indefinite GB recognition.
• UKCA strategy: this removes one argument for pursuing a UKCA mark purely to hedge against a future CE cut-off; manufacturers already investing in UKCA for other reasons — UK-only product lines, notified-body capacity concerns — are unaffected.
• Watch for implementing detail: MHRA's announcement is a policy confirmation; formal implementation of a long-term recognition regime typically follows in supporting regulatory instruments, which regulatory teams should track rather than assume are already in force in full legal detail.

What is still open

MHRA's announcement confirms the policy decision; it is a different thing from the underlying regulations being amended, which the UK government typically does through secondary legislation following a policy confirmation of this kind. The consultation also tested a proposed international reliance route — recognising approvals from other trusted overseas regulators — as a third option alongside the MDD extension and MDR/IVDR indefinite-recognition questions; this announcement does not resolve that proposal, which regulatory teams should expect to see addressed separately. Northern Ireland, which continues to follow EU device rules under its own separate arrangements, is not affected by a Great Britain market-access decision either way.

Frequently asked questions

What did the UK government confirm, and when?

On 21 October 2026, MHRA announced that the government will continue to accept CE-marked medical devices and in vitro diagnostics on the Great Britain market on a long-term, indefinite basis, rather than setting a future cut-off date for CE-mark reliance.

Which devices does this cover?

Devices and IVDs CE-marked under the current EU MDR and IVDR. Devices certified only under the older EU Medical Devices Directive (MDD) are not covered and remain on the transitional arrangements already in place.

What was the consultation behind this decision?

A targeted MHRA consultation, 16 February to 10 April 2026, drew more than 1,000 responses on proposals covering MDD transitional arrangements, MDR/IVDR indefinite recognition, and a possible international reliance route.

Does this change the UKCA mark or MHRA's oversight?

No. UKCA remains available as the UK's domestic route, and MHRA says it continues to oversee all devices on the UK market with strengthened post-market surveillance.