Medical devices

What is a medical device?

'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, for medical purposes, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body (Regulation (EU) 2017/745).

Medical devices are classified into classes I, IIa, IIb and III based on their intended use and risk.

Examples:

Prosthesis, defibrillator, breast implant, stent, suture, medical imaging device, condom, contact lens, contact lens solution, dental implant, medical software, syringe, hearing aid, bandage, dressing, crutch, wheelchair.

Some devices that are not intended for medical use but are based on similar technology are considered to be devices.

Examples:

Non-corrective or coloured contact lenses, skin and facial fillers, lipolysis equipment, equipment emitting high-intensity electromagnetic radiation (laser and intense pulsed light equipment for tattoo removal, hair removal, etc.).

What is an 'in vitro diagnostic medical device'?

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 providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations (Regulation (EU) 2017/746).

In vitro diagnostic medical devices are classified into classes A, B, C and D based on their intended use and risk.

Examples:

Pregnancy test, HIV test, home pregnancy test, COVID-19 test, cancer screening test