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UKCA marking requirements

Regulatory basis

UKCA marking requirements are set out in Regulation 6 and Schedule 3 of the UK MDR 2002, as amended by SI 2019/791. MHRA publishes detailed UKCA marking guidance at gov.uk/guidance/ukca-marking-for-medical-devices. The CE marking transitional acceptance policy was last updated by DHSC in June 2023.

Disclaimer

This site provides general information only. Transitional deadlines are subject to Government policy changes. Always verify the current position at MHRA's official guidance pages before making marking decisions.

What is the UKCA mark?​

The UKCA (UK Conformity Assessed) mark is the conformity marking for medical devices placed on the Great Britain market (England, Scotland, Wales). It replaced CE marking as the required conformity mark for GB from 1 January 2021.

The UKCA mark signifies that:

  • The device has been assessed against the Essential Requirements of UK MDR 2002
  • The appropriate conformity assessment procedure has been completed
  • A UK Declaration of Conformity has been issued by the manufacturer
  • For higher-risk devices: a UK Approved Body has been involved in the assessment

The UKCA mark is not recognised in the European Union or Northern Ireland. It is valid only for the Great Britain market.

Who affixes the UKCA mark?​

The manufacturer affixes the UKCA mark — or, for non-UK manufacturers, the manufacturer instructs the UKRP to ensure the mark is applied before the device is placed on the GB market.

The UKCA mark may only be applied after the conformity assessment procedure has been completed and the UK Declaration of Conformity has been issued. Applying the UKCA mark before completing conformity assessment is a breach of UK MDR 2002.

What the UKCA mark looks like​

The UKCA mark has a specified design. Key requirements:

  • The initials "UKCA" must be legible and indelible
  • The mark must have a minimum height of 5mm — unless the device's dimensions make this impossible, in which case it may be scaled down proportionally but must remain legible
  • The mark must not be distorted, altered, or obscured
  • No mark or inscription that could be confused with the UKCA mark may be used

The official UKCA mark image files are available from the UK Government at gov.uk/guidance/using-the-ukca-mark.

Where the UKCA mark must appear​

The UKCA mark must appear on:

  1. The device itself — where practicable
  2. The sterile packaging (for devices placed on the market in a sterile condition)
  3. The sales packaging

Where the device is too small or its shape makes it impracticable to affix the mark on the device, it must appear on:

  • The packaging
  • The instructions for use
  • Any accompanying document

UKAB identification number​

For devices assessed by a UK Approved Body (Class IIa, IIb, III, AIMD, IVD List A and B, self-test IVDs), the UKCA mark must be accompanied by the UKAB's four-digit identification number.

The number is placed immediately after the UKCA mark. If the UKAB number cannot be placed next to the UKCA mark due to space constraints, it must appear in the instructions for use and on the sales packaging.

Transitional CE marking acceptance (current position)​

As of May 2026, the Government policy is:

CE marking is accepted on the GB market for medical devices until 30 June 2030, provided that:

  1. The CE mark is valid (i.e., the underlying EU certification has not expired or been withdrawn)
  2. The device is CE-marked under EU MDR 2017/745, EU IVDR 2017/746, EU MDD 93/42/EEC (for legacy products under EU transitional provisions), EU AIMDD 90/385/EEC, or EU IVDD 98/79/EC
  3. The device is lawfully placed on the EU or UK market under those frameworks
  4. The manufacturer (or UKRP) has registered with MHRA via the Submissions portal
tip

Even during the CE transitional period, MHRA registration remains mandatory. A device bearing a CE mark cannot be placed on the GB market without MHRA registration. This is one of the most common compliance gaps among manufacturers relying on the CE transitional acceptance.

Transitional arrangements summary​

Mark usedGB market accessValid until
UKCA mark (UK MDR 2002 basis)YesOngoing (no expiry)
CE mark (EU MDR basis)Yes30 June 2030
CE mark (EU IVDR basis)Yes30 June 2030
CE mark (MDD/AIMD/IVDD legacy)Yes (where EU transitional still valid)30 June 2030
CE + UKNIYes (GB and NI)30 June 2030 for CE element
CE mark only (no MHRA registration)NoN/A — registration mandatory

CE + UKNI indication​

Some manufacturers opt to use a CE + UKNI marking combination. The UKNI indication shows that a UK Approved Body was involved in the conformity assessment for the Northern Ireland market.

Devices bearing CE + UKNI may be placed on both the GB and NI markets but may not be placed on the EU market.

This approach is used where:

  • A manufacturer uses a UKAB (rather than an EU Notified Body) for conformity assessment
  • The manufacturer needs both GB and NI market access
  • EU market access is not required (or is maintained via a separate EU Notified Body route)

UKCA mark on imported devices​

For devices manufactured outside the UK and imported for the GB market:

  1. The non-UK manufacturer completes conformity assessment under UK MDR 2002
  2. The non-UK manufacturer appoints a UKRP
  3. The UKCA mark is applied — the UKRP's name and address (rather than the manufacturer's) appear on the device label alongside the UKCA mark
  4. The UKRP registers the device and manufacturer with MHRA

Common UKCA marking errors​

ErrorConsequence
Applying UKCA mark before completing conformity assessmentBreach of UK MDR 2002; MHRA enforcement risk
No MHRA registration alongside CE-marked deviceDevice not lawfully on GB market
UKAB number missing on Class IIa/IIb/III devicesNon-compliance with marking requirements
CE mark used after 30 June 2030Device may not be placed on GB market
UKCA mark distorted or below 5mm without justificationNon-compliant marking
Non-UK manufacturer's address on label without UKRP addressNon-compliant labelling

Labelling transition planning​

Manufacturers currently relying on CE marking for the GB market should plan for UKCA transition:

  1. Audit current CE certificates — identify expiry dates and scope
  2. Identify UKAB for each product requiring third-party assessment
  3. Begin UKAB application well before 2030 (UKAB capacity is limited)
  4. Plan label change — UKCA mark, UKRP address, UKAB number
  5. Update MHRA registration when UKCA mark is adopted
  6. Run down CE-labelled stock or arrange re-labelling

Given UKAB capacity constraints, starting UKCA transition significantly before the 2030 deadline is strongly recommended — particularly for device portfolios requiring multiple UKAB certificates.

Official references​

ReferenceDescription
UK MDR 2002, Reg 6UKCA marking requirements
UK MDR 2002, Schedule 3Conformity assessment procedures
SI 2019/791UKCA mark provisions introduced post-Brexit
MHRA: UKCA marking for medical devicesDetailed MHRA guidance
gov.uk: Using the UKCA markUKCA mark artwork files
DHSC: June 2023 announcementExtension of CE marking acceptance to 30 June 2030