Do I need UKCA marking if I already have EU MDR CE marking for my medical software?

CE-marked medical devices can continue to be placed on the GB (Great Britain: England, Scotland, Wales) market under transitional rules. Devices certified under EU MDR can be sold in GB until 30 June 2030 (subject to certificate expiry). However, CE marking is not accepted in the long term — you will eventually need UKCA certification or to qualify for the international reliance route to maintain GB market access after the transitional periods end.

What is the MHRA international reliance route for medical devices?

The MHRA is introducing international reliance routes that allow manufacturers to use regulatory approvals from trusted overseas regulators — including EU MDR CE marks, FDA clearances, and Health Canada licenses — as the basis for a streamlined UK approval process. The framework is expected to finalise in 2026. This could significantly simplify UK market access for companies already certified under EU MDR.

How does UKCA certification differ from EU MDR CE marking for software?

UKCA certification under the current UK MDR 2002 (as amended) is based on the old EU Directives — similar to MDD rather than EU MDR. The new UK framework expected in 2026 will align GB requirements more closely with EU MDR standards. The certification process involves UK Approved Bodies (similar to EU Notified Bodies) rather than EU Notified Bodies. Northern Ireland remains under EU MDR.

What are the MHRA classification rules for software as a medical device in the UK?

The current UK MDR 2002 uses classification rules based on the old EU Medical Device Directive, including software classification rules. The new UK framework expected in 2026 is anticipated to introduce updated classification rules more aligned with EU MDR Rule 11. Until the new framework is in place, GB classification of SaMD follows the 2002 Regulations, and MHRA guidance documents on qualifying SaMD as a medical device apply.

Does UKCA apply to software sold in Northern Ireland?

No. Northern Ireland follows EU MDR and IVDR under the Windsor Framework — CE marking is required (and UKCA is not accepted) for medical devices placed on the NI market. This creates a split compliance requirement for manufacturers selling across both GB and Northern Ireland, requiring both CE and UKCA (or CE only with the understanding that CE remains sufficient for NI).

UKCA Marking for Medical Software 2026: Is CE Mark Still Valid? Deadlines & Routes

The UK regulatory landscape in 2026 — what is actually happening

Post-Brexit UK medical device regulation has been a moving target. The UK MDR 2002 — based on the old EU Directives — has been amended multiple times, CE mark acceptance has been extended repeatedly, and the promised "new UK framework" has been delayed. In July 2025, the MHRA published its response to the consultation on routes to market, setting out a clear policy direction. Here is where things stand as of early 2026:

CE mark transitional acceptance: EU MDR and IVDR compliant devices can be placed on the GB market until 30 June 2030. EU MDD-compliant devices can remain on the market until 30 June 2028 (general medical devices) or 30 June 2030 (IVDs). These are the current hard deadlines.
New UK framework: Key parts of the new UK medical device legislation are expected to apply from mid-2026. This will introduce more MDR-aligned classification rules, updated conformity assessment requirements, and the international reliance framework.
International reliance routes: The MHRA plans to introduce routes allowing manufacturers to leverage EU MDR, FDA, Health Canada, and other trusted regulatory approvals for streamlined GB market access. Details are expected in 2026.
UKCA marking: Remains valid and available. The new framework may move away from requiring the physical UKCA mark once a national UDI system is operational.

Northern Ireland exception: Northern Ireland follows EU MDR and IVDR under the Windsor Framework. CE marking is mandatory for the NI market. UKCA marking is not recognised in NI. If you sell in both GB and NI, you need a dual compliance strategy — CE for NI (and optionally GB during transitional period) plus a plan for UKCA or international reliance for GB post-transition.

MHRA SaMD classification — what the UK expects

Whether software qualifies as a medical device under UK regulation follows the same general principles as EU MDR — the software must have an intended purpose that constitutes a medical purpose. MHRA guidance on qualifying SaMD as a medical device closely mirrors EU MDR MDCG 2019-11.

The AI and Digital Regulations Service for health and social care (hosted by NHS England and NHSX) provides specific guidance on whether digital health technologies qualify as medical devices in the UK, including a decision support tool. This is particularly relevant for clinical decision support software, which occupies a grey zone in both EU and UK classification.

The new UK classification rules for software (expected 2026)

The new UK framework is expected to introduce classification rules for software more aligned with EU MDR Rule 11. This could result in some SaMD that was Class I under the old UK rules being reclassified into higher classes — requiring UK Approved Body involvement for products that previously self-declared. SaMD companies should assess their devices against the expected new classification rules now, not after the legislation takes effect.

UKCA certification — the process for medical software

For SaMD that requires third-party assessment (Class IIa equivalent and above), UKCA certification requires working with a UK Approved Body — the UK equivalent of an EU Notified Body. The process follows these steps:

Determine the applicable UK classification under UK MDR 2002 (or the new framework once in force)
Select a UK Approved Body — BSI Group UK, DEKRA Certification UK (AB 8505), IMNB UK, Intertek, and several others are designated Approved Bodies. Check the UK AB register on gov.uk
Prepare technical documentation — similar to MDD-era technical files, but with MHRA-specific requirements. Companies with existing EU MDR technical files can adapt these for UKCA, though some UK-specific differences apply
Submit to the UK Approved Body for conformity assessment
Register with MHRA — all manufacturers placing medical devices on the GB market must register with MHRA, regardless of device class
Appoint a UK Responsible Person (UKRP) — non-UK manufacturers must appoint a UKRP, similar to an EU Authorised Representative. The UKRP must be based in Great Britain (not Northern Ireland)

Critical deadline: The deadline for updating UK Responsible Person accounts in the MHRA Device Online Registration System (DORS) was 30 March 2026. If your UKRP has not updated their DORS account, there is a risk of market suspension. Check with your UKRP immediately.

Post-market surveillance requirements in GB — new from June 2025

New post-market surveillance legislation for GB took effect on 16 June 2025. Manufacturers of all medical devices placed on the GB market — including CE-marked devices benefiting from transitional provisions — must now comply with GB vigilance and post-market surveillance requirements.

This means: maintaining a GB-specific PMS process, submitting vigilance reports to MHRA for serious incidents, managing field safety corrective actions through MHRA, and having a documented complaint handling process. Companies that were previously focusing only on EU MDR post-market obligations now have a parallel GB obligation that must be managed.

Strategy: how to handle GB and EU together

For SaMD companies selling in both the EU and GB, the current optimal strategy is:

Certify under EU MDR (CE mark) as the primary certification — this covers the EU 27 member states plus EEA countries, and also satisfies GB requirements under the current transitional acceptance rules until 2030
Register with MHRA for GB, appoint a UK Responsible Person, and comply with the new GB PMS requirements from June 2025
Monitor the MHRA's international reliance route — when finalised, this may allow your EU MDR CE mark to be used as the basis for a streamlined permanent GB approval
Assess UKCA certification for insurance if your GB market is significant and you want to hedge against policy changes

Official sources & references

↗ MHRA — Regulating medical devices in the UK — MHRA / GOV.UK
↗ MHRA — UKCA conformity assessment guidance — MHRA / GOV.UK
↗ UK Medical Devices Regulations 2002 (SI 2002/618) — legislation.gov.uk

UKCA and the new UK medical device framework: what changes in 2026

The UK regulatory landscape in 2026 — what is actually happening

MHRA SaMD classification — what the UK expects

The new UK classification rules for software (expected 2026)

UKCA certification — the process for medical software

Post-market surveillance requirements in GB — new from June 2025

Strategy: how to handle GB and EU together

Frequently asked questions

Need help accessing the UK market for your medical software?