Legislation
Medical Devices Regulation
The UK rules governing how medical devices are classified, assessed and placed on the market, central to NHS device procurement.
Definition
Medical devices placed on the UK market are regulated principally under the Medical Devices Regulations 2002, as amended, enforced by the Medicines and Healthcare products Regulatory Agency. The regime governs how a device is classified by risk, what conformity assessment route applies, what marking it must carry, and what obligations follow once it is in use. For NHS procurement it sets the entry conditions: a device that is not lawfully placed on the market cannot be supplied under a public contract.
How it works in practice
Devices are classified by risk into Class I, Class IIa, Class IIb and Class III, with separate rules for in vitro diagnostic devices. Classification determines the assessment route. The lowest risk devices can in many cases be self declared by the manufacturer. Higher risk classes require the involvement of an approved body, which reviews the technical documentation and the quality management system before conformity can be declared.
Marking and registration follow from that assessment. Great Britain uses UKCA marking, with recognition of CE marking continuing under transitional arrangements that have been extended more than once, so suppliers should confirm the current position rather than rely on a remembered deadline. Northern Ireland operates under separate arrangements reflecting the Windsor Framework. In all cases the manufacturer, or a UK Responsible Person acting for a manufacturer based outside the UK, must register the device with the MHRA.
For bidders, the practical work is evidential. NHS frameworks and NHS Shared Business Services agreements typically require device registration details, conformity documentation, quality management certification such as ISO 13485, and confirmation of post market surveillance and vigilance arrangements. Specifications may also set requirements beyond the regulations, covering interoperability, decontamination, consumable compatibility or whole life cost, and those are scored on their merits rather than treated as compliance thresholds.
Common questions
What is the difference between UKCA and CE marking?
UKCA is the Great Britain conformity marking introduced after EU exit. CE is the European marking. Great Britain has continued to recognise CE marked devices under transitional arrangements which have been extended, so both routes may be acceptable depending on the device type and the current transition position. Confirm the position applicable at the time of tender.
Who is a UK Responsible Person?
Where a manufacturer is established outside the UK, it must appoint a UK Responsible Person to act on its behalf for registration and regulatory correspondence. The Responsible Person carries defined duties, including keeping technical documentation available and cooperating with the MHRA, and buyers may ask for its details.
Does the regulation cover software?
Yes. Software intended for a medical purpose, including some clinical decision support and diagnostic applications, can itself be a medical device and is classified and assessed accordingly. This catches suppliers who think of themselves as technology firms rather than device manufacturers, and it is a common source of late compliance problems in NHS digital procurements.
How does this affect framework call-offs?
Compliance is normally tested at framework admission, but it does not stop there. Call-off contracts usually require the supplier to maintain registration and marking throughout, to notify changes in regulatory status, and to manage field safety corrective actions. A lapse during the term is a contractual issue as well as a regulatory one.
