Since Brexit on 1 January 2021, the UK operates its own medical device marking system — UKCA — entirely separate from the EU CE mark. For manufacturers selling in both markets, this creates two parallel compliance pathways with different regulators, different Responsible Persons, and different registration databases.
| Regulatory Feature | EU CE Marking (MDR/IVDR) | UKCA Marking (MHRA) |
|---|---|---|
| Jurisdiction | 27 EU Member States + EFTA | Great Britain (England, Wales, Scotland) |
| Local Representative Needed? | EU Authorized Representative (EC-REP) | UK Responsible Person (UKRP) |
| Database Registration | EUDAMED Actor/SRN Registration | MHRA Device Registration Portal |
Quick answer — UKCA vs CE marking: CE marking is required for the EU and EEA (~450 million people). UKCA marking is required for Great Britain (~60 million). Non-EU manufacturers need an EU Authorized Representative for CE and a UK Responsible Person (UKRP) for UKCA. You can still place CE-marked devices on the GB market under MHRA transitional rules until 30 June 2028.
| Requirement | CE Mark (EU) | UKCA Mark (Great Britain) |
|---|---|---|
| Regulator | European Commission / national Competent Authorities | MHRA (UK Medicines & Healthcare products Regulatory Agency) |
| Market covered | All 27 EU member states + EEA (Iceland, Norway, Liechtenstein) | England, Scotland, Wales (not Northern Ireland) |
| Population | ~450 million | ~60 million |
| Legislation | EU MDR 2017/745 (medical devices) EU IVDR 2017/746 (in vitro diagnostics) | UK MDR 2002 (as amended) UK IVDR 2022 |
| Responsible person | EU Authorized Representative (EC REP) — mandatory for non-EU manufacturers | UK Responsible Person (UKRP) — mandatory for non-UK manufacturers |
| Registration database | EUDAMED — mandatory from 28 May 2026 | MHRA Device Registration — mandatory before market placement |
| Notified Body / CAB | EU Notified Body (25 designated under MDR) | UK Approved Body (CAB) — separate designation from EU NBs |
| Label requirement | CE mark + EU AR name and address | UKCA mark + UKRP name and address |
| Technical file format | EU MDR Annex II & III | Based on EU MDR structure — largely compatible |
| 2026 key deadline | 28 May 2026 — EUDAMED mandatory for all economic operators | 30 Jun 2026 — CE mark transitional recognition ends for Class IIb/III |
Northern Ireland operates under a special arrangement under the Windsor Framework. Medical devices sold in Northern Ireland can bear either the CE mark or the UKCA mark — both are accepted. Manufacturers do not need separate compliance for Northern Ireland if they are already CE-marked or UKCA-marked.
The UK has extended the recognition of CE-marked medical devices in Great Britain on a transitional basis. Current MHRA guidance allows:
This means if you already have EU CE marking, you can sell in Great Britain without UKCA during the transition period. After 2028, you will need either UKCA certification from a UK Approved Body or an equivalence route that may or may not exist at that time.
Largely yes — the UKCA technical file requirements closely mirror EU MDR. A manufacturer with a complete EU MDR Annex II/III technical file can use the same document as the basis for UKCA compliance, with minor UK-specific additions. This significantly reduces the cost of achieving both marks.
However, the Notified Body (EU) and Approved Body (UK) are separate entities. Certification from an EU NB does not automatically qualify as UKCA certification — you need a separate UK CAB assessment for Class IIa and above.
For most non-EU, non-UK manufacturers entering Europe for the first time: EU CE marking first.
Once EU MDR compliance is established, the incremental cost of adding UKCA is significantly lower than building both systems simultaneously.
Need help with CE marking or UKCA registration? View our EU MDR consulting services — fixed-fee, 5-day onboarding, all 27 EU member states covered. Transitioning from MDD? See our MDD to EU MDR gap analysis services.
The UK MHRA accepts CE marking under specified transition timelines. However, non-UK manufacturers must appoint a UK Responsible Person (UKRP) and register their medical devices with the MHRA to remain legally compliant.
CE marking signifies compliance with European Union regulations (such as EU MDR/IVDR), whereas UKCA (UK Conformity Assessed) marking applies strictly to products placed on the market in Great Britain.
If you sell in both the EU and Great Britain, yes. CE covers the EU; UKCA (or transitional CE recognition) covers Great Britain. Northern Ireland accepts either CE or UKCA.
NordMDR AB provides EU Authorized Representative services, EUDAMED registration and CE marking for non-EU manufacturers. Sweden-based. Fixed fees. 5-day onboarding. Free 20-min assessment.
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