Guide
Medical devices and equipment compliance
Regulatory requirements for medical devices including vigilance reporting and equipment maintenance.
Ensure medical devices have valid CE/UKCA marks, maintain them properly, and train staff. Report device incidents to MHRA promptly. Follow safety standards for radiation equipment.
- Check devices have CE/UKCA marking before use
- Classify devices by risk (I to III)
- Maintain devices as per manufacturer instructions
- Train staff on device use before operation
- Report adverse incidents to MHRA immediately or within 10 days
- Register with MHRA (£261 fee, annual renewal)
- Appoint Radiation Protection Adviser for ionising equipment
- Keep device inventory and incident logs
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.
Medical Devices Regulations
Medical devices must meet safety standards and carry appropriate marking:
MHRA registration for medical devices
Manufacturers and distributors of medical devices must register with MHRA and appoint a UK Responsible Person:
Radiation protection for ionising radiation
If you use X-ray, CT, radiotherapy or other ionising radiation equipment, you must appoint a Radiation Protection Adviser: