Medical Device Definition (MDD/IVD)
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 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.
The original Medical Device Directive (MDD) stated a Medical Device should conform to this description;
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
‘Intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.
And, in addition an Active Medical Device is described as;
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand-alone software is considered to be an active medical device
There was also the original directive on Active Implantable Medical Devices (AIMD) that had this definition:
…any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure….
The original In-Vitro Diagnostic Medical Device Directive (IVDD) gives the following definition for an IVD;
“any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment 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.
• concerning a physiological of pathological state, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.”
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.