UKCA Marking Strategy for Medical Devices & IVD
We've guided multiple manufacturers to obtain UKCA marking.
Why UKCA Marking presents a strategic hurdle for MedTech companies
Why UKCA Marking presents a strategic hurdle for MedTech companies
Entering the Great Britain market now requires the UKCA mark, under Medicines and Healthcare products Regulatory Agency (MHRA) guidance, meaning manufacturers must address new conformity assessment routes, appoint a UK Responsible Person ,register devices with the MHRA, and track shifting timelines.
How a MedTech Consultancy Can Help
Our team of UK regulatory experts takes the complexity out of the UKCA process. From classification and conformity assessment planning to dossier preparation, UK Responsible Person setup, labelling transitions and MHRA submission, we guide your device lifecycle end-to-end so you can enter or stay in the UK market with certainty and speed.
Satisfied Clients
Our UKCA Marking services cover multiple disciplines. Discover them all:
Regulatory Strategy & Classification
We analyse whether your device requires a UKCA route, determine the correct classification under the Medical Devices Regulations 2002 (UK MDR 2002), and map out the most efficient conformity assessment path.
Technical Documentation & Conformity Assessment Support
We assemble or review your technical file, align it with UK regulatory expectations (including Annex I of UK MDR), coordinate with a UK Approved Body where needed, and ensure readiness to affix the UKCA mark.
Registration & UK Responsible Person Setup
We support your MHRA device registration in Great Britain and act (or assist) as your UK Responsible Person, ensuring compliance with UK-based representation and ongoing regulatory obligations.
Labelling, Packaging & Post-Market Compliance
We review and update labelling, IFUs and packaging to meet UKCA mark and UK-specific operator details, plus assist with post-market surveillance (PMS) and vigilance systems under MHRA oversight.
Failure to address the UKCA transition, such as improper classification, outdated CE-only files, a missing UK Responsible Person appointment, or unconverted labelling, can result in market access suspension, import bans, longer approval cycles, and unplanned operational disruptions.
We apply a structured, audit-grade approach that begins early and remains aligned with your commercial objectives. Through strategic planning, meticulous documentation, approved-body liaison and post-market readiness, we help you affix the UKCA mark with confidence, so your entry or continuity in the UK market is seamless and worry-free.
Couldn't find your question?
What is the UKCA mark and when is it required?
The UKCA (UK Conformity Assessed) mark is the UK’s conformity marking for medical devices placed on the Great Britain market (England, Wales, Scotland), and is required under the UK MDR 2002 when placing a device on that market.
Can we still use our CE mark in the UK?
Yes, for now. CE-marked devices can continue to be placed on the market in Great Britain under transitional arrangements until the latest deadlines (for many devices until 30 June 2028 or 2030). After those deadlines, UKCA marking will become mandatory for most devices.
Do I need a UK Responsible Person?
If you are a non-UK manufacturer placing devices in Great Britain, you must appoint a UK Responsible Person to fulfil specified tasks (e.g., registration, documentation) under the UK MDR 2002.
How long does the UKCA-marking process take, and what are the risks of non-compliance?
The timeline depends on device classification and whether a UK Approved Body is required, ranging from a few months to several years for Class IIb/III devices. Non-compliance risks include refusal of market access, product recalls, MHRA enforcement, and costly remediation.