UKCA market access for medical devices

UKCA marking came into force in Great Britain in January 2021 when the UK left the European Union.

From this date to June 2024, Medical Devices and IVDs can be marked with either CE or UKCA. From July 2024, legislative transitional arrangements will apply for CE and UKCA marked Medical Devices and IVDs placed on the Great Britain market.

*Please note this represents current timelines that might be subject to change after New UK Regulation enters in force.

For Northern Ireland, even after 1 July 2024, a CE or UKNI mark will continue to be required for medical devices placed on the NI market and manufacturers will need to meet EU Regulations.

Based on MHRA acceptance of (EU) 2023/607, MDD/AIMDD certified medical devices may be placed on the GB market as follows (only if requirements set out in (EU) 2023/607 are met):

• Class III and IIb implantable non-WET devices till December 2027
• Class IIb WET, Class IIa, Class Im and Is devices till June 2028

Further guidance can be found on the UK Government website.

UKCA marking is the medical device manufacturer’s claim that a product meets the Essential Requirements (ER) of the UK MDR 2002, as amended,  and is a legal requirement to place a device on the market in Great Britain.

To understand which requirements you need to meet, you must classify the device and identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity.

We will review the route you chose to confirm its suitability, and work with you to execute the most efficient review process for the route selected. Our trusted review processes will allow you to build reliability and confidence into your UKCA marking project planning.

UK MDR 2002

Learn more on UK Regulation by visiting GOV.UK Guidance on regulating medical devices and IVDs in the UK.

*Please note that the UKCA marking timeline addressed in the FAQs is to be considered sensitive to the upcoming transitional arrangements and implementation of the new UK Regulation.

BSI provides the most experienced and efficient routes to global markets. Our expertise reaches all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We understand the challenges of achieving market access efficiently and safely, meeting commercial goals and regulatory requirements.

We developed our services to support manufacturers seeking timely and effective market access. Our services combine efficiency with the integrity, independence and thoroughness you expect from BSI.

Technical Documentation Review Services deliver the efficiency you need to be competitive in the market and maintain trust:

Allows you to work closely with your assigned BSI Technical Specialist on your product certification. These reviews are conducted remotely between you and the Expert via phone and email, as required.

Allows you to schedule your Technical Documentation review with a dedicated BSI Product Expert. The review is conducted remotely and scheduled to allow you to engage with your dedicated BSI Product Expert and provide responses to their questions. This ensures predictability in review planning and improves the process efficiency.

Note: Our services do not guarantee a UKCA certificate will be issued within a certain amount of working days, but are based on completing the review process with either a positive or negative recommendation. UKCA Dedicated is not available for devices utilising animal tissue, blood derivatives or medicinal substances.