Standards · Standard or regulation
UK MDR 2002 / UKCA
UK Medical Devices Regulations 2002 and the UKCA and CE marks
In plain words
What it covers.
The law for medical devices in Great Britain, enforced by the MHRA. Devices need a UKCA mark from a UK approved body, or a valid CE mark which is accepted in Great Britain for a transition period. Northern Ireland follows EU rules. All devices must be registered with the MHRA, and manufacturers outside the UK need a UK Responsible Person.
Who uses it: Manufacturers, UK Responsible Persons, NHS procurement and clinical engineering teams.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- UKCA marking and UK approved bodies
- Acceptance of CE marked devices
- MHRA device registration
- UK Responsible Person
- Vigilance and field safety notices
- Northern Ireland arrangements
Key points
What engineers need to know.
- The MHRA is the UK regulator for medical devices.
- A device needs a valid UKCA or accepted CE mark before it can be placed on the GB market.
- Check the mark, the declaration of conformity and the instructions at incoming inspection.
- Manufacturers must report adverse incidents and issue field safety notices.
- Hospitals that modify devices or use them off-label take on extra responsibility.
- Post-market surveillance rules were strengthened in 2025.
Medical City
Where you practise it.
- Commissioning incoming inspection and MDR / UKCA documentation
- S1-M007 The Installation Brief
- S1-M076 modification request