UKCA marking for software medical devices in Great Britain

Great Britain and Northern Ireland are two different markets

Start with geography, because the rules split along it. In Great Britain, meaning England, Wales and Scotland, the governing law is the Medical Devices Regulations 2002 (SI 2002/618), as amended, usually called UK MDR 2002. The EU MDR and IVDR do not apply there. Northern Ireland is different: under the Windsor Framework, the EU MDR and IVDR continue to apply, and a CE mark is required to place a device on that market.

This is why the UKNI indication exists. If a UK notified body carries out the mandatory third party conformity assessment for a device going to Northern Ireland, the device carries a combined CE and UKNI marking. The MHRA is explicit that devices bearing CE and UKNI can be placed across the whole UK but are not accepted on the EU market. A Great Britain based manufacturer supplying Northern Ireland also needs an authorised representative in the EU or Northern Ireland.

Registration has also diverged. Devices placed on the Great Britain market must be registered with the MHRA before they are placed on the market. For Northern Ireland, the MHRA states that from 28 May 2026 most devices are registered in EUDAMED instead, with narrow exceptions such as custom-made devices.

The practical rule: when a requirement applies only in England, Wales and Scotland, say Great Britain, not the UK. A plan that blurs the two will be picked up by any reviewer.

The CE route into Great Britain, and its dates

Great Britain continues to accept CE marked devices for a transitional period. The Medical Devices (Amendment) (Great Britain) Regulations 2023 (SI 2023/627) extended that acceptance by amending UK MDR 2002. Each route sits in its own regulation, and regulation 1ZA sets when each one ends. The period depends on which EU law your device was placed on the market under, not on when you started selling in Great Britain.

For software, two rows of the table below matter. If your software is certified under the EU MDR, you can rely on the CE mark in Great Britain until 30 June 2030. If it is a legacy device still on the market under the old Medical Devices Directive, the route runs to 30 June 2028, or earlier if a notified body certificate expires first.

That second route covers the most common legacy software case: software self-declared as Class I under the Directive, with its EU declaration of conformity drawn up before 26 May 2021, which the EU MDR now places in a higher class. Regulation 19B(3A) keeps a Directive Class I device on the route where the EU MDR would require a notified body for it. What it excludes is a device that is Class I under both regimes and needs no notified body under either. That device can use the CE route only as an EU MDR compliant device under regulation 19C, or take the UKCA route.

The CE route does not remove the Great Britain obligations, and this is where plans most often fall short. You still register with the MHRA before placing the device on the market. A manufacturer based outside the UK still appoints a UK Responsible Person: regulation 7A applies to every device placed on the market under Part II of UK MDR 2002, and the CE routes sit in Part II. And the Great Britain post-market surveillance requirements in Part 4A, in force since 16 June 2025, apply as well. Part 4A provides for this directly, defining the relevant safety requirements separately for devices placed on the market under regulation 19B and under regulation 19C.

How Great Britain classifies software, and why it may differ from your EU class

This is the point most software founders miss. UK MDR 2002 classifies general medical devices using the classification criteria in Annex IX of Directive 93/42/EEC, the old Medical Devices Directive (regulation 7). It does not use the EU MDR's Annex VIII, and it has no equivalent of MDR Rule 11.

Under those Directive rules, stand-alone software is treated as an active medical device. Active devices intended for diagnosis are Class IIa where they allow direct diagnosis or monitoring of vital physiological processes, rising to Class IIb where they are specifically intended to monitor vital physiological parameters and variations could result in immediate danger to the patient (Rule 10). Active therapeutic devices are addressed by Rule 9. All other active devices are Class I (Rule 12). Software that drives a device or influences its use falls in the same class as that device.

The result is that software classified Class IIa or higher under MDR Rule 11 can land in Class I under UK MDR 2002, and a great deal of it does. The National Commission into the Regulation of AI in Healthcare, reporting in September 2026, found that most software and AI-enabled devices in Great Britain are currently self-declared as Class I, and said the classification scheme was not designed for technologies of this kind. The MHRA's software guidance confirms the consequence: a Class I device that is neither sterile nor measuring reaches the market on the manufacturer's own declaration, while Class IIa and above needs a UK Approved Body.

Treat this carefully. A lower Great Britain class is a legitimate outcome of the current law, but it has to be reached rule by rule for your intended purpose, documented, and defensible to the MHRA. Software that allows direct diagnosis or monitoring of vital physiological processes is Class IIa under Rule 10, not Class I. And a Class I route in Great Britain does not change your EU class, so if you sell in both markets your technical documentation carries two classification rationales.

What the UKCA route itself requires

If you choose, or eventually need, the UKCA route, the core requirements come from UK MDR 2002 and are distinct from anything you hold for the EU.

• Conformity assessment: a Class I device that is neither sterile nor measuring follows the self-declaration procedure, meeting the Annex VII obligations and declaring conformity itself (regulation 13(1)). A Class I device with a measuring function, or one placed on the market sterile, also needs a UK Approved Body, whose involvement is limited to the metrology or sterility aspects (Annex VII, section 5, of Directive 93/42). Classes IIa, IIb and III need a UK Approved Body. An EU Notified Body certificate does not count for UKCA.
• UKCA marking: the mark goes on the device or its packaging where practicable and appropriate, in a visible, legible and indelible form (regulation 10). For software without a physical label, decide early where the mark will appear and confirm that choice against current MHRA labelling guidance.
• UK Responsible Person: required where the manufacturer is based outside the UK, on this route as on the CE route (regulation 7A).
• Registration: the device is registered with the MHRA before it is placed on the Great Britain market.
• Post-market surveillance: Part 4A of UK MDR 2002, inserted by SI 2024/1368 and in force since 16 June 2025, requires a post-market surveillance system based on a post-market surveillance plan. An EU PMS system is a useful starting point, but the Great Britain requirements are their own legal text: map them against your system rather than assuming coverage.

What is moving, and how firm each piece is

Several decisions that matter to software manufacturers are not yet made. Separate what is law from what is proposed.

• Indefinite recognition of CE marked devices, a consultation with no outcome: the MHRA consulted from 16 February to 10 April 2026 on recognising EU MDR and IVDR compliant devices indefinitely, extending the MDD arrangements to align with EU timelines, and adding a reliance route for devices classified higher in Great Britain than in the EU. As of 29 September 2026 no outcome has been published.
• Pre-market regulations, a draft not yet made: the MHRA published a draft Medical Devices (Amendment) Regulations 2026 through WTO notification on 8 May 2026, with a stakeholder survey that closed on 19 June 2026. It includes an international reliance framework for devices approved in Australia, Canada and the USA. As at 29 September 2026 it had not been made.
• Reliance on FDA 510(k) for software, a stated intention: in its July 2025 response to consultation, the government said the reliance route based on US 510(k) clearance would be expanded to include software as a medical device, subject to demonstrating entire equivalence. That is a policy decision awaiting legislation, not a route you can use today.
• Removal of the UKCA mark itself, a conditional intention: the same response said the government intends to remove the requirement for UKCA marking, conditional on manufacturers assigning UDI and the UDI being searchable in a public database. It will only happen after that database is operational and the UDI transitional period has ended.
• Software classification, a recommendation only: the National Commission into the Regulation of AI in Healthcare published its recommendations on 10 September 2026. Its first asks the MHRA to review the UK regulations for software and AI, including a classification approach that addresses the known limitations of self-declared Class I devices. If that is taken forward, the Class I outcome described above is likely to narrow.

Choosing a route for your software

None of those changes alters what you must do today, but all of them could change what you should plan for. Confirm the current MHRA position before you commit budget to a date.

For an EU MDR certified software manufacturer with no Great Britain specific pressure, the CE route is usually the right answer until the recognition decision lands. It avoids a second conformity assessment, and 30 June 2030 gives planning room, provided the Great Britain obligations that apply either way are in place.

The UKCA route becomes worth costing in three situations: your software classifies as Class I under the Directive rules and a self-declared UKCA mark gets you to market faster than your EU certification; you hold a legacy Directive device whose Great Britain route will end before you can move it to the EU MDR; or you need certainty beyond 2030 and are not prepared to wait on a consultation outcome.

• Classify your software under Directive 93/42 Annex IX as well as under MDR Annex VIII, and record both rationales.
• If your software is a legacy Directive Class I device, check whether the EU MDR would require a notified body for it; that decides whether regulation 19B covers it.
• Check your certificate basis and expiry date against the table above.
• Register with the MHRA, appoint a UK Responsible Person if you are based outside the UK, and map your post-market surveillance against Part 4A, whichever route you take.
• If you supply Northern Ireland, plan for CE marking and EU registration rules, not Great Britain rules.
• Diarise a check of the MHRA consultation page and the pre-market instrument before any decision that depends on a date after 2028.