Medical devices and equipment compliance

Healthcare providers must ensure medical devices are safe, properly maintained, and staff are trained in their use. You must also report adverse incidents to the MHRA via the Yellow Card scheme as soon as possible - manufacturers face separate statutory vigilance deadlines, strengthened by the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, in force since 16 June 2025.

Medical Devices Regulations

Medical devices must meet safety standards and carry appropriate marking:

Medical Devices Regulations 2002 (as amended)

Medical devices placed on the UK market must meet safety and performance requirements, carry CE/UKCA marking, and comply with post-market surveillance and vigilance obligations. Healthcare providers must report adverse incidents.

What are medical devices

Medical devices range from simple items (bandages, thermometers) to complex equipment (MRI scanners, ventilators, implantable devices). Software and apps can also be medical devices.

Device classification

Class I: Low risk (e.g. bandages, walking sticks)
Class IIa: Medium risk (e.g. hearing aids, ultrasound)
Class IIb: Medium-high risk (e.g. ventilators, defibrillators)
Class III: High risk (e.g. heart valves, implantable devices)

CE/UKCA marking

Devices on the Great Britain market can carry CE marking (accepted until 30 June 2028 for devices certified under the EU medical devices and active implantable devices directives, and until 30 June 2030 for IVDs and devices certified under the EU MDR/IVDR) or UKCA marking as an alternative. CE marking remains the requirement in Northern Ireland. Marking demonstrates conformity with safety and performance requirements.

Provider responsibilities

Healthcare providers must:

Only use devices with valid CE/UKCA marking
Maintain medical devices in safe working order
Ensure staff are trained in device use
Report adverse incidents and near misses to MHRA
Implement medical device management systems

Vigilance - reporting incidents

Report to MHRA when a device has:

Malfunctioned or deteriorated
Been subject to inadequate labelling or instructions
And this has led to death or serious injury, or could do so if it recurs

The immediate (death or serious public health threat) and 10-day (serious injury) reporting deadlines are manufacturer duties under the vigilance system, strengthened by the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, in force since 16 June 2025. As a healthcare provider, report adverse incidents to MHRA via the Yellow Card scheme as soon as possible.

Step 1: Maintain inventory of all medical devices with device details and maintenance schedules
Step 2: Verify devices carry valid CE or UKCA marking before procurement
Step 3: Implement preventative maintenance programme based on manufacturer instructions
Step 4: Ensure equipment testing (PAT testing for electrical devices) is up to date
Step 5: Provide device-specific training to staff before use
Step 6: Report adverse incidents via MHRA Yellow Card scheme as soon as possible
Step 7: Investigate incidents locally and implement corrective actions
Step 8: Maintain device incident log and review trends

Report a medical device incident

MHRA registration for medical devices

Manufacturers and distributors of medical devices must register with MHRA and appoint a UK Responsible Person:

MHRA Registration (UK Responsible Person)

MHRA Registration (UK Responsible Person) - Medical devices manufacture/supply

Regulator: Mhra
Typical fee: Annual fee of around £300 per chargeable GMDN Level 2 category (from 1 April 2026; previously £261 flat per registration)
Timeline: 3-6 months
Frequency: annual
Legal basis: Medical Devices Regulations 2002 (as amended)

Manufacturers, importers, and distributors of medical devices must register with MHRA. Devices on the Great Britain market can carry CE marking (accepted until 30 June 2028 for directive-certified devices and 30 June 2030 for IVDs and EU MDR/IVDR-certified devices) or UKCA marking as an alternative; overseas manufacturers need a UK Responsible Person. Class I devices can self-certify; Class IIa/IIb/III require conformity assessment by an approved or notified body. Medical device vigilance reporting mandatory for manufacturers (incidents, field safety notices). Annual registration renewal required.

Radiation protection for ionising radiation

If you use X-ray, CT, radiotherapy or other ionising radiation equipment, you must appoint a Radiation Protection Adviser:

Radiation Protection Adviser (RPA) Appointment

Radiation Protection Adviser (RPA) Appointment - Ionising radiation use (medical)

Regulator: Hse
Typical fee: RPA service contract (varies)
Timeline: Must be in place before using radiation equipment
Frequency: ongoing
Legal basis: Ionising Radiations Regulations 2017 (IRR17); IR(ME)R 2017

All employers using ionising radiation (X-ray, CT, fluoroscopy, radiotherapy) must appoint qualified RPA. RPA provides radiation safety advice, dose assessments, and equipment testing. Separate requirement for Medical Physics Expert (MPE) under IR(ME)R 2017. Local Rules and risk assessments mandatory. HSE enforces IRR17; CQC enforces IR(ME)R. Staff must be designated as classified workers if high dose exposure likely.

Medical devices and equipment compliance

Healthcare premises and equipment requirements

UKCA and CE marking for medical devices

Medical devices: placing on the GB market

MHRA authorisation for medicines and medical devices

Working in the civil nuclear industry

Medical Devices Regulations

MHRA registration for medical devices

Radiation protection for ionising radiation

Related guides in Risk Assessment

Medical Devices Regulations

MHRA registration for medical devices

Radiation protection for ionising radiation