Navigate Post-Brexit Compliance with Confidence – Your Trusted Partner for UKCA Medical Device Certification

UKCA Certification of Medical Devices – Post-Brexit Compliance Made Simple

Since the UK’s departure from the European Union, the UK Conformity Assessed (UKCA) marking has become mandatory for medical devices placed on the market in England, Scotland, and Wales. UKCA certification replaces CE marking in the UK and is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

At Reghelps, we offer expert consulting support for UKCA certification—helping medical device manufacturers adapt to post-Brexit requirements efficiently. Whether you’re transitioning from CE, launching a new device, or need a UK Responsible Person (UKRP), our team ensures a smooth and compliant process aligned with UK MDR 2002.

UKCA Marking Provisions and Approved Bodies

The phrase “UKCA Mark” refers to any product conformity marking necessary to sell medical devices in the United Kingdom. Similarly, “Approved Body” encompasses additional appointment types such as Designated Body or Technical Assessment Body (TAB).

Unless specific arrangements, such as medical equipment, are in place, all items put on the UK market must be UKCA labelled as of January 1, 2023.
After December 31, 2021, qualified Northern Ireland goods can be put on the UK market with an EU conformity assessment marking, such as the CE marking.
CE Mark for medical devices will be recognised in the UK until June 30, 2023, providing that UK and EU laws stay unchanged.
Products that are currently CE certified based on an EU Notified Body assessment will be needed to be examined by the UK Approved Body for UK market access from January 1, 2023.

Conformity assessment by Notified bodies operating from the UK will no longer be recognised in the EU as of January 1, 2021, and certifications issued by such bodies will no longer be valid. As a result, existing notified Bodies in the United Kingdom will cease to exist and be replaced by UK Approved Bodies with the same scope, and they will carry out the same tasks but under UK MDR 2002.

UKCA Marking Consultants

The UKCA Compliance Consulting team from I3CGlobal has the sound knowledge, technical capability, and large headcount to start any project in no time. In addition, we have end-to-end solutions for compliance needs.

Identify the legislation, standards and route of UKCA Marking.
Review of Technical Documentation
If enforcement action is taken against the foreign manufacturer, EU Representative should cooperate with the authorities.
Perform any other responsibilities outlined in the written mandate that they and the manufacturer have agreed on.
Coordinate with Approved Bodies during technical file review and onsite audit

The following devices are exempted from using UKCA Mark

Custom-made device
Devices used exclusively for clinical investigation
An in Vitro diagnostic device used for performance evaluation
Non-compliant devices used on humanitarian grounds

UKCA Marking and related FAQ’s

Why UKCA Certification Matters for Medical Device Companiesadminreg2025-08-06T09:44:10+05:30

Why UKCA Certification Matters for Medical Device Companies

After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.

Who Needs UKCA Marking?adminreg2025-08-06T09:43:19+05:30

Who Needs UKCA Marking?

All medical devices sold in England, Scotland, and Wales must be UKCA certified unless CE marked under special transition rules (valid until mid-2028 for some devices)

MDR Classification

Technical Documentation

Risk Management

European Authorised Representative

Medical Device UKCA Marking

UK Responsible person