Here to stay: Government confirms long-term recognition of CE-marked medical devices and IVDs in Great Britain

In February 2026, the Medicines and Healthcare products Regulatory Agency (the “MHRA”) launched a consultation proposing indefinite recognition of CE-marked medical devices and in vitro diagnostic devices (“IVDs”) in Great Britain, which we examined in our previous article, “CE marks in Great Britain: the end of uncertainty?”. On 21 October 2026, the Government published a response, confirming its decision that CE-marked medical devices and IVDs will continue to be recognised in Great Britain on a long-term basis (Northern Ireland continues to apply the EU MDR and IVDR under the Windsor Framework.) 

What has been decided

Over 1,000 responses were received from patients, healthcare organisations and the industry during the consultation period. The key outcomes are:

• No second UK approval route will be required for devices already approved for the EU market. Over 90% of devices registered in Great Britain carry a CE mark.
   
• Separately, the UKCA mark remains the domestic approval pathway and is being modernised through a pre-market statutory instrument, the draft Medical Devices (Amendment) Regulations 2026, which is expected to be laid before Parliament by the end of 2026 and to come into force around autumn 2027. Some provisions, including new requirements on what claims can be made about devices and IVDs, will apply with no transition period.
   
• The Government intends to recognise EU MDR and IVDR-certified devices indefinitely, and to accept EU MDD devices only until the end of the EU transition period (currently 31 December 2028). 

What this means in practice

The outcome was widely expected following the consultation. The Association of British HealthTech Industries (“ABHI”) has pushed for this for some time and welcomed the decision as giving greater regulatory certainty, avoiding unnecessary duplication for manufacturers and helping to safeguard the continued supply of health technologies in Great Britain. Lawrence Tallon, the MHRA’s Chief Executive, said the decision “gives patients, the NHS and industry the long-term certainty they need on access to medical devices”. In practice, this will make it much easier for companies operating in the Great Britain to plan their regulatory strategies without having to factor in a separate UK approval. British patients benefit from continuing access to health technologies they rely on. 

A few points are worth noting: 

• The recognition will apply across all device risk classes - there will be no separate international reliance route for EU devices/IVDs with a higher risk classification in the EU than under UK Medical Devices Regulation 2002, as was proposed in the consultation.
   
• Access to Great Britain will depend on the EU certificate remaining valid. If a notified body suspends or withdraws it, the manufacturer would lose access to both markets at the same time. Open findings in the EU technical file therefore matter on both sides of the Channel, and certificate management should be prioritised accordingly.
   
• CE recognition does not mean less scrutiny. The MHRA will still oversee the safety of every device on the UK market, using the strengthened post-market surveillance and reporting requirements already in place, including the Yellow Card scheme, and working with international partners on safety concerns.
   
• Manufacturers can now plan for Great Britain alongside their EU strategy with more confidence on the applicable requirements. The UKCA route remains, but it is likely to become a route chosen for particular reasons, such as first-to-market innovative products, rather than a market access requirement.

Timeline

The response confirms that the legislative changes needed to implement the Government’s decision will be made, subject to parliamentary approval, before 30 June 2028 (which is the date until which general medical devices compliant with the EU MDD can currently be placed on the market in Great Britain). This is necessary for GB to align with the end of the EU MDR transition period for EU MDD certificates (currently 31 December 2028). Until then, the existing deadlines continue to apply.

Context: wider reform of the UK medical devices regime

Indefinite recognition of CE marks is the latest step in a wider, still-unfolding reform programme. The Life Sciences Sector Plan committed to faster, risk-proportionate and predictable routes to regulatory approval, including international reliance and recognition routes for medical devices alongside an innovation-friendly domestic UKCA route.   The MHRA’s recently published Strategy 2030 builds on that commitment, promising clearer pathways, earlier engagement, faster routes to patient access and deeper international partnerships to reduce duplication.   

The Government has also tabled amendments to the Health Bill that would give the MHRA powers to develop a medical device licensing regime. Whilst the regime itself is yet to be designed, the intention is that devices placed on the GB market through a domestic route could be licensed uniformly by the MHRA as a centralised regulator, rather than relying on third-party conformity assessment. Taken together, these developments show the Government and the regulator taking steady, consistent steps to bring stability and predictability to the framework, while opening new routes that encourage innovation and secure patients’ access to health technologies.

Looking ahead

Significant milestones remain ahead. The main ones are the pre-market statutory instrument, expected to be laid before Parliament by the end of 2026, and the Health Bill’s progress through the House of Lords, where Committee stage begins on 28 October.   Even so, after years of uncertainty since Brexit, the direction of travel is finally clearer, and for the medtech sector that clarity is perhaps the most welcome news of all.

This article was co-authored by Victoria Mitchell, PhD, Trainee Solicitor