Evaluation of medical devices

Evaluation of Medical Devices or products is required to determine which directive is applicable for the product so that the CE Certification process can be determined. Further it must be determined  which product category is applicable for the Medical Devise product concerned.  In the European Union Medical Device regulation there are 3 categories:

• Medical Device (MD)
• In vitro Diagnostic (IVD)
• Active implantable medical device (AIMD)

MEDICAL DEVICE (MD)

A Medical Device (MD) is defined in Directive (2007/47/EC) as: “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 by such means.”

IN VITRO DIAGNOSTICS MEDICAL DEVICE (IVD)

An In Vitro Diagnostic Medical Device (IVD) is defined in Directive (98/79/EC) as: “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 or pathological state, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential recipients, or
• to monitor therapeutic measures.””

Specimen receptacles are considered to be in vitro diagnostic medical devices. ’Specimen receptacles` are devices that can be vacuum and specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

ACTIVE IMPLANTABLE MEDICAL DEVICE (AIMD)

An Active Implantable Medical Device (AIMD)
is defined in AIMD Directive (90/383/EEC) as:
“Any 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”.

According to the directive, an active device relies on a source of electrical energy or any source of power other than that directly generated by the human body or gravity. This means that the function of the device involves using the source of power to perform useful work.  Only transmission of heat, light, pressure or vibration does not mean that a device is active.

Examples of types of devices normally covered by this AIMD directive include:

• implantable cardiac pacemakers
• implantable defibrillators
• leads, electrodes, adaptors for the above
• implantable nerve stimulators
• bladder stimulators
• sphincter stimulators
• diaphragm stimulators
• cochlear implants
• implantable active drug administration devices
• catheters, sensors for active drug administration devices