UKCA for Medical Devices, MHRA Registration, and UKCA Certification Guidance (Process of Approval)

UKCA Marking is vital for ensuring medical device compliance in the UK. Our specialized support ensures a seamless MHRA registration process, guiding your product’s entry into the market with regulatory adherence.

What is UKCA Marking for Medical Devices?

The UKCA (United Kingdom Conformity Assessment) marking is a logo that signifies a medical device’s compliance with the UK MDR 2002 requirements. This mark confirms that the device is safe, fit for its intended purpose, and complies with the legislation related to safety. It is a mandatory requirement for medical devices intended for the Great Britain market, which includes England, Wales, and Scotland.

UK MDR 2002

Learn more about UK regulations by visiting GOV.UK Guidance on Regulating Medical Devices and IVDs in the United Kingdom.

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UKCA Market Entry for Medical Devices

The UKCA marking is a declaration by a manufacturer indicating that their product adheres to the Essential Requirements (ER) set in the UK MDR 2002, as amended. It’s a mandatory requirement for the placement of medical devices in the Great Britain market.

The process of determining the relevant requirements involves classifying the device and selecting the appropriate conformity assessment route. This selection dictates the necessary steps to demonstrate compliance.

We’ll evaluate the chosen route to ensure its appropriateness and collaborate with you to streamline the review process for your UKCA marking project. Our established review procedures are designed to instill reliability and confidence into your project planning.

Who Needs UKCA Marking for Medical Devices?

If you are involved in the manufacture, distribution, or import of medical devices in the UK, you may be required to obtain UKCA marking. This includes:

Medical device manufacturers based in the UK
Distributors of medical devices in the UK
Companies importing medical devices into the UK

MHRA Registration Process for Medical Devices (UKCA Marking Process)

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK’s regulatory authority responsible for ensuring that medicines and medical devices are safe and effective.

Classification: Determine the classification of your medical device according to the European Union’s Medical Device Regulation (MDR).
Conformity Assessment: Conduct a conformity assessment to demonstrate that your device meets safety and performance requirements.
Technical Documentation: Prepare technical documentation that includes device descriptions, intended use, and clinical data.
Application Submission: Submit your application to the MHRA through the Medical Devices Information System (MDIS).
Evaluation: MHRA will evaluate your application and technical documentation to ensure compliance with safety and performance requirements.
Registration Certificate: If your application is successful, MHRA will issue a registration certificate, allowing you to sell your medical device in the UK.

Also Read: Guide to MHRA medical device registration

The UKCA Marking Timelines

The implementation of UKCA marking began in Great Britain in January 2021, coinciding with the UK’s departure from the European Union.
From January 2021 until June 2025, Medical Devices and IVDs could be marked with either CE or UKCA. Following this period, starting in July 2025, specific legislative transitional arrangements would be applicable for Medical Devices and IVDs marked with CE or UKCA and placed on the Great Britain market.

Please note that this timeline reflects current regulations, which might change once the New UK Regulation is enforced and receives parliamentary approval.

For Northern Ireland, even post+-July 1, 2025, a CE or UKNI mark remains necessary for medical devices placed on the NI market. Manufacturers will be required to comply with EU Regulations.
Subject to the MHRA’s acceptance of (EU) 2023/607, MDD/AIMDD certified medical devices can be placed on the GB market based on the criteria outlined in (EU) 2023/607:
Class III and IIb implantable non-WET devices until December 2027
Class IIb WET, Class IIa, Class Im, and Is devices until June 2028

For more detailed guidance, please refer to the information available on the UK Government website.

How will Operon Strategist Help You Get UKCA Marking for Medical Devices?

Operon Strategist offers tailored guidance to medical device manufacturers, distributors, and importers seeking UKCA marking. Our expertise includes comprehensive assessments, strategic advice, regulatory support, documentation assistance, MHRA liaison, and ensuring timely compliance with evolving UK regulations. We streamline the process, ensuring your medical devices meet the necessary standards for market entry in Great Britain. Contact us today to get started on your journey to UKCA marking for medical devices.