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 Classification||Risk Level||Examples|
|Class I||Low||Elastic bandages and diagnostic test kits.|
|Class IIa||Low - Medium||Blood glucose monitors and powered wheelchairs.|
|Class IIb||High - Medium||Surgical lasers and implantable pacemakers.|
|Class III||High||Heart valves and implantable neurostimulators.|
|Approval timeline||Class 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 period||3 years (Under MDR 5 years)|
|Fees||Application registration :- £100|