Medical Device Definition (MDR/IVDR)
It is important to understand the definition of a Medical Device, or an In-Vitro Diagnostic Medical Device (IVD), as many manufacturers are confused about this, in particular in respect of products which may be regarded as borderline to a pharmaceutical, cosmetic, or to personal protective equipment.
The new EU Regulations provide an “upgrade” to the definitions of such devices in the previous Directives.
The key definitions are spelled-out within the directives and in particular if there is a need to clarify if a product has a pharmacological effect (i.e. a medicine), a mechanical effect (i.e. a device), or just surface treatment (i.e. a cosmetic) to the human body.
With the Medical Device Regulation (MDR) we have a slightly different definition to that in the Directive, however they lead to the same conclusion – the need to consider the primary mode of action i.e. will it have a mechanical action or pharmacological action, and this is key. This new regulation (MDR) defines the term “medical device” as;
Any “instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for any of the following medical purposes:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability or injury, where prevention of disability and injury is excluded
• Investigation, replacement or modification of an anatomical, physiological or pathological process
• Providing data via in vitro examination of samples derived from a human body
• Products intended for cleaning, disinfection and sterilization of medical devices
• Devices for the control and support of conception, even if they achieve their intended purpose by pharmacological, immunological or metabolic means.
Included into this Regulation’s scope now are some additional devices and some that were originally considered exempt cosmetic devices;
• Products introduced into the body via surgically invasive means in order to modify anatomy.
• Products and substances used for facial or other subcutaneous filling.
• Equipment used for liposuction, lipolysis or lipoplasty.
• High-intensity electromagnetic radiation equipment used for skin treatments such as tattoo and hair removal
• Equipment using electrical or magnetic currents to stimulate the brain.
The In-Vitro Diagnostic Medical Device Regulation (IVDR) now gives the following definition which is much less vague:
‘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, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;
It should be noted that there is a combination possibility as some Medical Devices will incorporate pharmacological substances for them to operate and vice versa.
The key to having the correct definition is to remember what the primary function of a product is; a mechanical action with a pharmacological adjunct? or a pharmacological action with the need for a device to make it work?
It is important for manufacturers to understand and classify the devices to these regulations before they start any processes to place them on the market.