UKCA marking for medical devices
To UKCA mark a device for Great Britain, classify it under Medical Devices Regulations 2002 regulation 7, meet the essential requirements (regulation 8), pass conformity assessment for its class (regulation 13), declare and mark it (regulation 10) and register it with the MHRA (regulation 7A). A CE mark is accepted instead until 30 June 2030.
The requirement in plain English
Classify (Medical Devices Regulations 2002 regulation 7). Great Britain uses the 18 rules of Annex IX of the old general devices directive, as Medical Devices Regulations 2002 Schedule 2A modifies them, not the 22 rules of EU MDR. There is no software rule: standalone software counts as an active device, so much of it lands in Class I where EU MDR would say Class IIa or higher. Software that drives a device takes that device’s class.
Meet the essential requirements (Medical Devices Regulations 2002 regulation 8). Annex I of the directive sets them: safety, performance, design and construction, and the information supplied with the device. You show how each one is met in your technical documentation.
Complete conformity assessment (Medical Devices Regulations 2002 regulation 13). A Class I device is self-declared under the directive’s Annex VII, but if it is supplied sterile or has a measuring function, an approved body checks those aspects. Classes IIa, IIb and III need a UK approved body, through a full quality assurance audit or type examination combined with verification, production quality assurance or product quality assurance, depending on class. Approved bodies are listed on the government’s UK Market Conformity Assessment Bodies database.
Declare and mark (Medical Devices Regulations 2002 regulation 10). You sign a declaration of conformity and affix the UKCA mark visibly and legibly to the device or its sterile pack, the sales packaging and the instructions for use, with the approved body’s number where one was involved.
Register and appoint (Medical Devices Regulations 2002 regulation 7A). Before placing a device on the market you register it with the MHRA and pay the fee (Medical Devices Regulations 2002 regulation 53), £240 per application since 8 February 2024. A manufacturer based outside the UK appoints a sole UK Responsible Person, who registers the device, holds the technical documentation and declaration for the MHRA, passes on incident reports and cooperates on corrective action. The MHRA can proceed against them as if they had placed the device on the market (Medical Devices Regulations 2002 regulation 60).
Watch it on the market (Medical Devices Regulations 2002 Part 4A). Since June 2025 every device placed on the Great Britain market needs a surveillance plan, incident reporting to the MHRA and periodic reports.
The CE alternative (Medical Devices Regulations 2002 regulation 19C). A device that meets EU MDR in full is treated as meeting the main UK requirements while the UK accepts CE marks.
| Device and EU basis | Accepted in Great Britain until |
|---|---|
| CE marked under EU MDR, including Class I self-declared | 30 June 2030 |
| CE marked under the old general or active implantable directives | Certificate expiry or 30 June 2028, whichever is sooner |
| Northern Ireland, any device | Not applicable: EU MDR applies and UKCA is not recognised |
This is guidance to help you understand the requirement, not legal advice.
What good looks like
A 25-person German company sells a CE-marked Class IIa triage app to NHS trusts. It relies on CE acceptance today and plans UKCA well before 2030.
Its regulatory lead keeps a Great Britain classification rationale beside the EU one. Walking the 18 retained rules, the app lands in Class I, because it drives no device and engages no energy or monitoring rule; the rationale says so and cites the MHRA’s software guidance. The UKCA route is therefore a self-declaration, and the company notes the date it will switch.
A UK Responsible Person, a regulatory consultancy in Leeds, is appointed by a written agreement that lists every duty in regulation 7A and how fast each is done. The UK Responsible Person registered the app with the MHRA before the first sale and updates the registration within the month when a version changes the intended purpose.
The surveillance plan has a Great Britain section: which complaints reach the MHRA, who files a serious incident report within 15 days, and the cadence of the periodic report for the app’s Great Britain class. One technical file serves both markets, with a short Great Britain annex for the classification, the declaration and the labelling.
Evidence an auditor expects
- Great Britain classification rationale: the approved body, or the MHRA on inspection, checks that the class follows the retained rules, not the EU ones.
- Technical documentation against the essential requirements (required): the approved body samples how each requirement is met.
- UKCA declaration of conformity (required): names the device, the class, the procedure followed and the approved body.
- Approved body certificate: for Class IIa and above, and for the sterile or measuring aspects of a Class I device, current and covering the device.
- MHRA registration confirmation (required before placing on the market): the MHRA checks that every device sold is registered.
- UK Responsible Person agreement: written evidence of authority, which the UK Responsible Person must give the MHRA.
- Labelling and instructions for use: the UKCA mark and any approved body number in the right places.
- Part 4A records: the surveillance plan, incident reports and periodic reports for the Great Britain class.
Common mistakes
Assuming the Great Britain class equals the EU class
The rule sets differ, most of all for software. Classify under each and keep both rationales; the Great Britain class decides your UKCA route and your report cadence even while you rely on a CE mark.
Treating CE acceptance as a full exemption
Registration, the UK Responsible Person and Part 4A apply to CE-marked devices too. Manufacturers who skip registration because they hold a CE mark cannot lawfully place the device on the market.
Reading 30 June 2028 as the end date for a directive certificate
Acceptance ends when the certificate expires if that comes first. Track each certificate’s own expiry date.
Shipping UKCA-only stock to Northern Ireland
Northern Ireland needs the CE mark, with UKNI beside it where a UK notified body did the assessment. Check where stock goes before you label it.
A UK Responsible Person appointed by a one-line letter
The MHRA expects written evidence of authority, and the duties in regulation 7A only work if the agreement says who does what and how fast. Write them into the contract.
How Sted helps
- For Great Britain Sted classifies a device under the 18 Annex IX rules retained in UK MDR 2002, where software has no rule of its own, and when you rely on a CE mark in Great Britain it still gives the Great Britain class, because that class decides your eventual UKCA route and your post-market duties there.
- The class is information for you and your approved body to check, not a legal determination.
- Sted classifies a medical device for the EU and Northern Ireland under EU MDR, Great Britain under UK MDR 2002, Canada under the Medical Devices Regulations (SOR/98-282), Australia under the Therapeutic Goods (Medical Devices) Regulations 2002, and the United States (from the FDA product code you confirm). Home raises one classification task per device product, whatever its markets: it asks whether the product is a medical device and how it works, facts every market’s rules use, and gives an EU class only if the product is sold in the EU. A second task, for the other markets, follows when the product qualifies and is sold in any of them.
- Devices sold only in other markets get no class from Sted yet.
- Sted treats UK MDR 2002 as applying when a product qualifies as a medical device, you intend to sell it in the UK, and you hold an economic-operator role for it, and it reports two positions: Great Britain under the UK MDR 2002 route, noting when a UK Responsible Person is needed because you are not established in the UK, and Northern Ireland under EU MDR through the Windsor Framework; both positions are met by one set of quality, risk, usability and software records.
- For UK MDR 2002 Sted’s knowledge base carries one procedure, the Post-Market Surveillance and Vigilance Procedure (PRC-PMSV), and one record template, the Problem Report (REC-MDPR), tagged to it; the quality-system, risk, usability and software records it needs come through ISO 13485, ISO 14971, IEC 62366-1 and IEC 62304, and the Great Britain classification comes from the retained Annex IX rules.
Sted does not act as a UK Responsible Person, register devices with the MHRA or sign a declaration of conformity. The manufacturer and its approved body do.
Related guides and terms
- UK MDR 2002 and UKCA marking: the whole Great Britain and Northern Ireland position.
- EU MDR device classification: the EU rules your Great Britain class may differ from.
- EU MDR conformity assessment and notified bodies: the CE route the UK still accepts.
- How Sted decides what applies to you: where Sted shows the Great Britain class beside the EU one.
- Supplier due diligence: choosing and checking a UK Responsible Person like any other critical supplier.
- Documented information: the controlled records the UKCA file is built from.
Frequently asked questions
When does the UKCA mark become compulsory for medical devices?
There is no single date yet. CE-marked devices under EU MDR are accepted in Great Britain until 30 June 2030, and those under the old directive until their certificate expires or 30 June 2028, whichever is sooner. The MHRA consulted in 2026 on accepting CE marks indefinitely, so check the gov.uk guidance before you plan around either date.
Can I put both the UKCA and the CE mark on a device?
Yes, a device that meets both regimes may carry both marks. That suits products sold in Great Britain and the EU from one production line. Stock meant for the whole UK needs the CE mark, because Northern Ireland does not recognise UKCA.
Do I need a UK Responsible Person if I sell in Great Britain under a CE mark?
Yes, if your company is based outside the UK. The UK Responsible Person requirement and MHRA registration apply to every device placed on the Great Britain market, whichever mark it carries.