UKCA Certification & GB Market Access for Medical Devices
We help you choose the right route to the Great Britain market, CE recognition or UKCA marking, and handle classification, UK Approved Body assessment, MHRA registration, UK Responsible Person and post-market surveillance.
What is UKCA marking?
UKCA (UK Conformity Assessed) marking shows that a medical device meets the UK Medical Devices Regulations 2002 (UK MDR 2002). It is the UK's own conformity mark for the Great Britain market, regulated by the MHRA.
CE-marked devices are still accepted in Great Britain for now, and the UK government has confirmed plans to keep recognising them. Whichever mark you use, you must register your devices with the MHRA, appoint a UK Responsible Person if you are based outside the UK, and meet GB post-market surveillance rules.
Routes to the Great Britain market
Which route you use depends on your current certification. All routes need MHRA registration, a UK Responsible Person for non-UK manufacturers and GB post-market surveillance.
| Route | Suits | Current position |
|---|---|---|
| CE marking (MDD / AIMDD) | Legacy devices certified under the old EU directives | Accepted until 30 June 2028, or earlier certificate expiry |
| CE marking (EU MDR / IVDR) | Devices certified under the EU regulations | Accepted until 30 June 2030; indefinite recognition confirmed in October 2026, subject to legislation |
| UKCA marking | Devices without valid CE marking, or makers who want a UK certificate | Available now through a UK Approved Body or self-declaration (Class I) |
| International reliance | Devices approved in the EU, USA, Canada or Australia | Planned by the MHRA, not yet in force |
How we get your device onto the GB market
A clear route from choosing your pathway to staying compliant after launch.
- 1
Choose your route
CE or UKCAWe check your certificates and deadlines and recommend CE recognition or UKCA marking.
- 2
Appoint a UK Responsible Person
Non-UK manufacturersWe act as, or help you appoint, the UKRP who registers and represents you.
- 3
Classify under UK MDR 2002
Class I to IIIWe confirm the UK class, which can differ from your EU MDR class.
- 4
Prepare UK technical documentation
Essential requirementsWe align your technical file, labelling and UK Declaration of Conformity with UK requirements.
- 5
UK Approved Body assessment
Class Is/Im, IIa, IIb, IIIWe support the UK Approved Body audit and review, or the self-declaration for Class I devices.
- 6
MHRA registration
Before placing on marketWe register your devices with the MHRA through the UK Responsible Person.
- 7
Post-market surveillance
GB PMS rules 2025We set up PMS plans, PSURs, serious incident reporting and trend reporting for GB.
Our UKCA and MHRA services
UKCA marking FAQs
Is UKCA marking mandatory for medical devices?
Not yet for most devices. Great Britain currently accepts CE-marked devices: under the MDD or AIMDD until 30 June 2028, and under EU MDR or IVDR until 30 June 2030. In October 2026 the UK government confirmed plans to recognise CE-marked devices indefinitely, subject to new legislation. UKCA marking remains the UK's own route and is needed for devices without valid CE marking.
Does Northern Ireland accept UKCA marking?
No. Under the Windsor Framework, Northern Ireland follows EU MDR and IVDR. Devices placed on the Northern Ireland market need CE marking, or CE UKNI marking where a UK Notified Body was used.
Do I need a UK Responsible Person?
Yes, if your company is based outside the UK. A UK Responsible Person is required to register your devices with the MHRA and act on your behalf, whether your devices carry CE or UKCA marking.
Do all devices need to be registered with the MHRA?
Yes. Every medical device and IVD placed on the Great Britain market must be registered with the MHRA, by the UK manufacturer or by the UK Responsible Person for overseas manufacturers.
What changed for post-market surveillance in June 2025?
New GB post-market surveillance rules came into force on 16 June 2025. They set requirements for PMS plans, periodic safety update reports and PMS reports, serious incident reporting timelines and trend reporting for devices on the GB market, whether CE or UKCA marked.
Can an EU Notified Body issue a UKCA certificate?
No. UKCA certificates for Class Is, Im, IIa, IIb, III devices and higher-risk IVDs can only be issued by a UK Approved Body designated by the MHRA.
Not sure which GB route fits your device?
Send us your device and certificate details using the form below and we'll recommend the right route at no cost.
