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Regulatory Services

UKCA marking

Given the stringent requirements on patient safety and device performance, accessing Great Britain market brings challenges that can delay your product launch.

It is critical to work with a UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

BSI UK (0086) is a leading full-scope Approved Body under the UK MDR 2002, as amended. We review your medical device to ensure conformity against UK legislation by offering a range of flexible certification services providing you with efficient pathways to bring your product to market.

UKCA marking is the medical device manufacturer’s claim that a product meets the Essential Requirements (ER) of the UK MDR 2002, as amended.

UKCA 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.

Why choose BSI for your UKCA marking?

BSI UKAB is designated for all devices covered by UK MDR 2002.

  • General Medical Devices.

  • Active Implantable Medical Devices.

  • In-vitro Diagnostic Medical Devices.

UKCA Timeline

UKCA marking came into force in January 2021 when the UK left the EU. From this date to June 2025, Medical Devices and IVDs can be marked with either CE or UKCA.

From July 2025, legislative transitional arrangements will apply for CE and UKCA marked Medical Devices and IVDs placed on the Great Britain market.

For Northern Ireland, even after 1 July 2025, 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

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Why BSI

BSI provides 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.

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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