UK market access with a trusted approved body

From 1st July 2024 new UK legislation will come into force.

Additional guidance can be found at GOV.UK dedicated webpage.

UKCA marking came into force in Great Britain in January 2021 when the UK left the European Union. UKCA Certification may be required for certain classifications of medical devices and is available from the UK appointed Approved Bodies, such as BSI (0086). There will be a transition period to 30 June 2023 to allow existing CE certifications to be replaced by the new UKCA mark. From 1 January 2021, medical devices must be registered with the MHRA before being placed on the UK market irrespective of whether UKCA marked or CE marked. Please refer to the timelines published by MHRA for the risk class of your medical device. A UK Responsible Person (UKRP) is required to be appointed if the manufacturer is based outside the UK.

For Northern Ireland, the EU MDR and IVDR will apply from 26 May 2021 and 26 May 2022, respectively. Even after 1 July 2023, a CE mark will continue to be required for medical devices placed on the Northern Ireland market and manufacturers will need to meet EU regulations.

*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.

The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated in the UK after the transition period with the EU has ended (from 1 January 2021).

BSI UK is the first UK Approved Body designated for Medical Devices and IVDs; we are the only UK Approved Body designated for all three types of devices:

• Medical Devices

• Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
• Under Part II of the Medical Devices Regulation as they apply in Northern Ireland (SI 2002 NO 618, as amended) (UK MDR 2002) until 25 May 2021

• Active Implantable Medical Devices

• Under Part III of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
• Under Part III of the Medical Devices Regulation as they apply in Northern Ireland (SI 2002 NO 618, as amended) (UK MDR 2002) until 25 May 2021

• In-vitro Diagnostics Medical Devices

• Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
• Under Part IV of the Medical Devices Regulation as they apply in Northern Ireland (SI 2002 NO 618, as amended) (UK MDR 2002) until 25 May 2022

Depending of the classification of the devices, we review technical documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your technical documentation. This proficiency gives confidence in your certification to you and your key stakeholders.

We offer two review services:

• Standard

Our standard service reviews are completed by experienced BSI Product Experts, giving you confidence in the review.

• Dedicated

This service allows you to schedule your Technical Documentation review with a dedicated BSI Product Expert.

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.