UKCA Marking for Medical Devices After Brexit

Since the United Kingdom left the European Union (Brexit), the regulatory landscape for medical devices has changed. The UKCA mark (United Kingdom Conformity Assessed) has replaced CE marking for many products sold in Great Britain (England, Wales, Scotland). For exporters and medical device manufacturers, understanding UKCA marking for medical devices after Brexit is vital to continue supplying devices to the UK market legally.

This article explains what UKCA marking is, who it applies to, how to obtain it, transitional rules, and best practices for exporters.

What Is UKCA Marking for Medical Devices?

UKCA marking is the UK’s own conformity mark used to show that a product meets the required UK regulations. For medical devices, it indicates compliance with the UK Medical Devices Regulations (UK MDR 2002, as amended) and relevant standards.

When devices carry the UKCA mark, they can be legally placed on the market in Great Britain (England, Scotland and Wales). Northern Ireland has a different scheme (NI-marking under the Northern Ireland Protocol).

The UKCA mark is analogous to the CE mark, but it is specific to UK regulation and requires compliance with UK-specific rules.

Why Did the UK Introduce UKCA Marking?

Before Brexit, the CE mark sufficed for the UK and EU medical device markets. Post Brexit:

• The UK needed its own regulatory identity and control of standards.
• UK authorities wanted to tailor regulations and ensure oversight specific to the UK.
• To reduce dependency on EU-notified bodies and enable UK-based conformity assessment.
• To ensure continuity in medical device regulation while retaining alignment with international standards.

Thus, UKCA marking was introduced to replace the CE obligation (for Great Britain) and to allow the UK to manage its own device conformity framework.

Who Needs UKCA Marking for Medical Devices?

UKCA marking is required for:

• Manufacturers intending to place medical devices in Great Britain.
• Importers or distributors placing devices on the GB market, unless an alternative compliance route is recognised.
• Devices that were previously CE-marked may need UKCA conversion if marketed after Brexit transition deadlines.

Devices solely in Northern Ireland may not need UKCA; they operate under the NI mark system.

Which Medical Devices Require UKCA Marking?

UKCA applies to devices covered under UK MDR: higher risk classes especially. Devices include:

• Class I (sterile or measuring)
• Class IIa, IIb
• Class III (high risk)
• Active implantable devices

Low-risk Class I (non-sterile, non-measuring) may have simpler conformity routes, but UKCA may still need to be declared for many devices.

What Are the Steps to Get UKCA Marking for Medical Devices?

Here’s the step-by-step process:

Step 1: Determine Device Classification

• Use UK MDR rules (similar to EU MDR) to classify your device (Class I, IIa, IIb, III).

Step 2: Select Conformity Assessment Route

• Depending on risk class, you may self-certify (Class I) or use a UK Approved Body for intervention (higher classes).

Step 3: Prepare Technical Documentation

• Compile a UK Declaration of Conformity, device specifications, risk assessment, clinical data, labelling, post-market plans, etc.

Step 4: Conduct Conformity Assessment

• If needed, engage a UK Approved Body to audit your QMS and review your technical documentation.

Step 5: Apply UKCA Mark

• Affix the UKCA mark (with Approved Body number if applicable) on your device, packaging, labelling, and documentation.

Step 6: Register with the UK Regulator

• Register your device on the UK government’s device registration portal (MHRA) if required.

Step 7: Post-Market Obligations

• Monitor device performance, report incidents, update documentation, and comply with UK vigilance system.

What Are the Transitional Arrangements & Deadlines?

To ease transition, the UK allowed continued CE marking acceptance for some time after Brexit, but:

• That acceptance period is time-limited and is phasing out.
• After the deadline, only UKCA-marked devices will be accepted in Great Britain.
• Exporters need to transition CE-marked device to UKCA before the deadline.

Exporters must track current MHRA guidance and deadlines, as the UK government may extend or modify transitional periods.

What Are Common Challenges for Exporters?

• Finding UK Approved Bodies for conformity assessment—less capacity compared to EU.
• Adjusting existing CE technical documentation to align with UK MDR requirements.
• Labeling and symbolism changes (e.g., replacing “CE” with “UKCA”).
• Registration and data submissions to UK regulatory systems (MHRA database).
• Managing parallel CE and UKCA regimes if selling in both EU and UK markets.

How to Maintain Compliance and Monitor Changes?

• Subscribe to updates from MHRA (UK’s Medicines & Healthcare products Regulatory Agency).
• Review MHRA guidance on medical devices (UK).
• Engage regulatory consultants skilled in UK device processes.
• Audit your labeling, software, claims, and documentation regularly.
• Keep an eye on Brexit-related adjustments or regulatory amendments.