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United Kingdom Medical Device Regulations

Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices in the United Kingdom.
Medical Device Definition
An instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease."
This includes a wide range of products, such as surgical instruments, diagnostic equipment, and implantable devices.
Medical Device Classification System
International ClassificationRisk LevelExamples
Class ILowElastic bandages and diagnostic test kits.
Class IIaLow - MediumBlood glucose monitors and powered wheelchairs.
Class IIbHigh - MediumSurgical lasers and implantable pacemakers.
Class IIIHighHeart valves and implantable neurostimulators.
Approval Process
ClassificationApproval procedure
Class I
  • The manufacturer is responsible for ensuring that the device conforms to the relevant regulations and standards.
  • The manufacturer must notify the Medicines and Healthcare products Regulatory Agency (MHRA) that the device has been placed on the market.
Class IIa
  • The manufacturer must submit a technical file or a declaration of conformity to a notified body, which will assess the device's conformity with the relevant regulations and standards.
  • The manufacturer can affix a CE mark to the device, indicating that it conforms to the relevant European Union regulations.
  • Class III device manufacturers must submit a technical file or a declaration of conformity, a clinical evaluation report, and results of clinical investigations t 1 a notified body, which will assess the records of the device's conformity assessment and make them available to the MHRA
Class IIb
Class III
Additional Information
Approval timelineClass I:- 1 month, Class IIa & IIb:- 3 to 6 months, Class III:- Up to 12 months. The approval process can be delayed if additional information or testing is required.
License validity period3 years (Under MDR 5 years)
FeesApplication registration :- £100
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