UKCA vs CE Marking for Medical Products: What UK Clinics Need to Know (2026)

Since Brexit, UK healthcare procurement has had to navigate a new regulatory landscape. UKCA and CE marking are both valid in Great Britain — but not interchangeably, and not forever. This guide explains what each mark means, which applies to your purchases, and what to check before buying medical products for your clinic or care home.

What is CE Marking?

CE marking (Conformité Européenne) indicates that a product meets EU safety, health, and environmental requirements. It has been the standard mark for medical devices and PPE sold across Europe for decades.

CE marking is still accepted in Great Britain until 31 December 2027 under transitional arrangements — after which UKCA marking will be required for most products placed on the GB market.

What is UKCA Marking?

UKCA (UK Conformity Assessed) marking is the UK's post-Brexit equivalent of CE marking. It applies to products sold in England, Scotland, and Wales (Great Britain). It does not apply to Northern Ireland, which continues to follow EU rules under the Windsor Framework.

UKCA marking requires conformity assessment by a UK Approved Body — the UK equivalent of EU Notified Bodies.

Key Differences: UKCA vs CE

  • Geographic scope: UKCA = Great Britain only; CE = EU + accepted in GB until end of 2027
  • Regulatory body: UKCA assessed by UK Approved Bodies; CE assessed by EU Notified Bodies
  • Northern Ireland: CE marking required (not UKCA) under the Windsor Framework
  • Deadline: CE marking accepted in GB until 31 December 2027; UKCA required after that
  • Self-declaration: Some lower-risk products can self-declare UKCA; higher-risk medical devices require third-party assessment

Medical Devices: Additional Considerations

Medical devices in the UK are regulated by the MHRA (Medicines and Healthcare products Regulatory Agency). From July 2025, all medical devices placed on the GB market must be registered with the MHRA — regardless of whether they carry CE or UKCA marking.

  • Class I devices (low risk, e.g. bandages, examination gloves) — manufacturer self-declaration acceptable
  • Class IIa/IIb devices (medium risk, e.g. surgical gloves, diagnostic equipment) — third-party conformity assessment required
  • Class III devices (high risk, e.g. implantables) — strictest assessment requirements

PPE: What to Check

For PPE purchased for clinical use in Great Britain:

  • CE marking is currently valid and widely available
  • Check the relevant EN standard is cited on the product (e.g. EN 455 for gloves, EN 14683 for masks)
  • Ensure the manufacturer or importer is identifiable on the packaging
  • From 2028, look for UKCA marking on new stock

Practical Checklist for Procurement Managers

  • ✅ Check whether the product carries CE or UKCA marking
  • ✅ Confirm the relevant EN standard is met (request datasheet if not on packaging)
  • ✅ For medical devices, verify MHRA registration of the manufacturer
  • ✅ For Northern Ireland facilities, ensure CE marking is present
  • ✅ Plan ahead: begin transitioning to UKCA-marked products before the 2027 deadline

Medvana Products and Compliance

All medical supplies and PPE sold by Medvana carry appropriate CE or UKCA marking and meet relevant EN standards. Browse our compliant ranges:

Frequently Asked Questions

Is CE marking still valid in the UK in 2026?

Yes. CE marking is still accepted in Great Britain until 31 December 2027 under transitional arrangements. After that date, most products will require UKCA marking to be placed on the GB market. Northern Ireland continues to require CE marking under the Windsor Framework.

Do I need to check MHRA registration when buying medical devices?

From July 2025, all medical devices placed on the GB market must be registered with the MHRA. When purchasing medical devices, you should verify that the manufacturer or UK responsible person is registered with the MHRA. Reputable suppliers will be able to confirm this.

What is the difference between UKCA and CE marking for PPE?

Both UKCA and CE marking indicate that PPE has been assessed against relevant safety standards. CE marking is assessed by EU Notified Bodies; UKCA marking by UK Approved Bodies. For PPE purchased in Great Britain, both are currently valid. The key is to ensure the product also cites the relevant EN standard (e.g. EN 455 for gloves, EN 14683 for masks).

When does UKCA marking become mandatory in the UK?

UKCA marking becomes mandatory for most products placed on the Great Britain market after 31 December 2027. Healthcare procurement managers should begin planning their transition to UKCA-marked products ahead of this deadline to avoid supply disruption.

Reviewed by: Medvana Procurement Team  |  Last updated: May 2026  |  Standards referenced: UK Medical Devices Regulations 2002 (as amended), MHRA Guidance 2025, UK Biocidal Products Regulation, EN 455, EN 14683, Windsor Framework

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