10. How the UKCA mark works

Last Updated on 06/11/2025 by Sarah Sarsby

Manufacturers can access the GB market either through UKCA certification or via recognition of CE certification until July 2028 for general medical devices, or July 2030 for IVDs, depending on the applicable EU legislation.

The UK government is pursuing proposals for comprehensive reform of devices regulation under UKCA. In the meantime, the current Medical Devices Regulations 2002 continue to apply. Devices in NI remain subject to different arrangements under the Windsor Framework, with ongoing alignment to EU rules.

In light of the government’s July 2025 response to its consultation on medical device regulation, and the planned introduction of a new UK medical device regime in 2026, CE-marked devices may continue to be placed on the GB market during the transitional period. The government has also announced plans to consult later in 2025 on indefinite recognition of CE-marked devices.

Additionally, the government intends to remove the mandatory requirement for UKCA marking on devices and associated labelling that have undergone UK conformity assessment. This change will be conditional on the assignment of a Unique Device Identifier (UDI), which must be searchable in a publicly accessible database expected to be operational in 2026.

Transitional Arrangements notwithstanding, manufacturers are able to obtain UKCA Certification currently. As outlined in Sections 2-5 above, obtaining a UKCA mark is materially similar to obtaining a CE mark – the main difference being that the Declaration of Conformity (for self-certified Class I devices or general IVDs) or Assessment Certificate (for 3^rd-party assessed Class I Special Function, Class II-and-above device, self-test IVD, IVD included in Annex II list B, or IVD included in Annex II list A) is issued by a UK Approved Body (UK AB) rather than an EU Notified Body (EU NB) against UK MDR 2002 (as amended).

For more information on UKCA marking, please see:

• MHRA – Regulating Medical Devices in the UK – UKCA Mark and UK ABs: This section of MHRA’s device regulation page provides an in-context summary of the UKCA Mark UK ABs
• MHRA – Approved Bodies for Medical Devices: Here MHRA outlines their definition of UK ABs, including their role and function within the UK medical device regulation process
• MHRA – Medical Devices – Conformity Assessment and the UKCA Mark: Detailed guidelines on conformity assessment and the UKCA mark for medical devices in particular (including Assessment Routes, International Standards Compliance, Clinical Investigations (if applicable), the UKCA Mark and NI considerations)
• DBT – Using UKCA Marking: General guidance on using the UKCA Mark, including logo-type assets