Definition
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.
A full definition can be found in Article 2(1) of the MDR.
Medical Device Examples:
- dental and surgical instruments
- bandages and splints
- treatment chairs and hospital beds
Definition
‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.
A full definition can be found in Article 2(2) of the IVDRn
Vitro Diagnostic Medical Device Examples:
- • pregnancy tests
- • blood glucose monitors
MHRA guidance
The HRA provides an e-learning module on medical devices, explaining the regulations and considerations for clinical investigations or other research studies of medical devices across the UK. The module can be accessed here.