Medical Devices, Brexit and the UKCA

Medical Devices, Brexit and the UKCA

The UK has officially ceased to be a member of the European Union. We will continue to keep you informed on the new UKCA and future UK regulation of medical devices and in vitro diagnostics.

The UK has officially ceased to be a member of the European Union. We will continue to keep you informed on the new UKCA and future UK regulation of medical devices and in vitro diagnostics.
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Medical Devices, Brexit and the UKCA
Medical Devices, Brexit and the UKCA
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UKCA market access for medical devices

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 webinar FAQs

UKCA for medical devices and IVDs

Download our UKCA webinar FAQs to know more about taking devices to market in Great Britain post Brexit.

Download the FAQs

What is UKCA marking?

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.

UKCA FAQs

UKCA for medical devices and IVDs

Download our UKCA marking FAQs to learn more about taking devices to market in Great Britain.

Download the FAQs

Webinar | The UK: Still an attractive place to do medtech business?

In this webinar hosted by Swiss Medtech, Maddalena Pinsi and Jay Katta from BSI give an update on UKCA for medical devices.

Access the presentations >

UKCA timeline

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

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.

UKCA timeline 2023

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

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

Further guidance can be found on the UK Government website.

Download UKCA timeline

Registration of devices

All medical devices, IVDs and custom-made devices must be registered with the MHRA before being placed on the Great Britain market. This applies to devices of all classes.

Registration of device

ISO 13485 after brexit

Read the news article to learn more about the validity of accredited management system certificates issued by UK based conformity assessment bodies following the UK's departure from the EU.

Read the article

UKCA on-demand webinars

Why choose BSI for your UKCA marking?

BSI UK is the only UK Approved Body (0086) designated for Medical Devices and IVDs and the only one designated for all three types of devices covered by UK MDR 2002:

  • General Medical Devices
  • Active Implantable Medical Devices
  • In-vitro Diagnostic Medical Devices

As a manufacturer, this facilitates the certification of your medical devices and saves you from having to manage your product portfolio between different UK Approved Bodies.

Our team has a unique set of expertise that allows to provide a rigorous review of your Technical File/Design Dossier. You will be assigned a dedicated BSI Technical Specialist to work with throughout your product certification journey and will remain your point of contact thereafter.

UKCA Excellence

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:

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