CE marked medical devices UK rules after the October 2026 change

CE marked medical devices in the UK after the indefinite recognition decision

Yes. CE marked medical devices and IVDs can still be placed on the UK market. On 21 October 2026 the government confirmed indefinite recognition for EU MDR and EU IVDR devices in Great Britain, but that change is not law yet. The end dates in force are still 30 June 2028 and 30 June 2030.

The GOV.UK announcement says the government "will continue to accept CE marked medical devices on a long-term basis", covering devices and IVDs. It also says UKCA "remains the current domestic approval route" and "is being modernised through the pre-market statutory instrument". The government will seek enabling powers through primary legislation for a future licensing approach, including software and AI medical devices.

What changed for CE marked medical devices

The government response intends to recognise devices certified under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) indefinitely. It would keep the conditions in regulations 19C, 30A and 44ZB of the UK Medical Devices Regulations 2002 (UK MDR 2002).

Devices certified under the old Medical Devices Directive (MDD) do not get that open-ended recognition. The response says they will be accepted until the EU transition ends, "currently, 31 December 2028", while regulation 19B conditions stay. Whether a given MDD device qualifies still depends on its certificate. MDD devices placed compliantly on the EU or Great Britain market before those transition arrangements end will still be allowed.

The government does not intend to limit recognition to the same or a lower GB class, or to open a separate route where the GB class is higher. For combination products, the device part stays eligible, but it may still have to meet requirements under the Human Medicines Regulations 2012.

The deadlines that still apply

None of this is in force yet. The response says the MHRA will legislate for these MDR, IVDR and MDD changes before 30 June 2028, subject to parliamentary approval. As of 22 October 2026, that instrument had not been made.

Until it is, regulation 1ZA of the UK MDR 2002, substituted by SI 2023/627 (in force 30 June 2023), still sets the cut-offs. Regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028. Regulations 19C, 44ZA and 44ZB cease at 23:59 on 30 June 2030.

The MHRA timelines for acceptance of CE marked devices in GB give the same dates. That page, published 16 February 2026, says the transition arrangements "remain in place" while the consultation is considered.

The response does not mention the Active Implantable Medical Devices Directive (AIMDD) or the In Vitro Diagnostic Medical Devices Directive (IVDD). Their current dates stand unless a later instrument changes them.

The timelines guidance adds limits. Custom-made devices compliant with the MDD or AIMDD are no longer accepted. An expired certificate cannot be relied on unless the EU has deemed it valid. Certificates extended under EU MDR Article 120 or IVDR Article 110 can be used for Great Britain.

CE marking doesn't remove GB duties

A CE mark is not market access in Great Britain. The response keeps domestic duties:

• Register the device with the MHRA before placing it on the GB market (Regulating medical devices in the UK).
• Appoint a UK Responsible Person if the manufacturer is based outside the UK.
• Meet GB post-market surveillance rules. The PMS regulations have applied since 16 June 2025 to both CE and UKCA marked devices. They do not apply to individual devices placed on the market before that date.
• Make the technical documentation and certificate of conformity available in English.
• Comply with enforcement notices under the Medicines and Medical Devices Act 2021.

Rely on the legislation for what binds you today.

UKCA and CE marking side by side

UKCA stays available next to CE recognition. The response says the UKCA mark "will remain available as a route to market", and that pre-market legislation for UKCA devices is being drafted. That draft covers unique device identification (UDI), implant cards and up-classification of implantable devices.

Northern Ireland already requires a CE mark

This decision is for Great Britain. In Northern Ireland the EU MDR and IVDR apply under the Windsor Framework, and MHRA guidance says "CE marking is required for the Northern Ireland market". A UKCA-only device cannot be sold there.

A device certified by a UK notified body carries a combined CE and UK(NI) marking. It can be sold across the UK, but not in the EU. A GB manufacturer placing devices on the Northern Ireland market needs an authorised representative based in the EU or Northern Ireland.

Qualifying Northern Ireland goods can move the other way: onto the GB market "with a valid CE marking on an indefinite basis", under the UK Internal Market Act 2020. The MHRA page on unfettered access already set that out before 21 October 2026.

What to use until the law changes

Keep GB plans on the dates in force in the table above. An Article 120 or Article 110 extension can keep the certificate valid for the certificate-expiry limit. It does not move the statutory GB date.

If Parliament passes the planned change, MDR and IVDR recognition would have no GB end date. MDD acceptance would follow the EU transition end, currently 31 December 2028, and only where the device is eligible. RegAffairs AI's answer on CE marked devices points at the stored MHRA sources for this question.

Check the amending instrument before you drop the AIMDD or IVDD dates from a file.