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• 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;

Active Implantable Devices - AIMD 90/385/EEC In-vitro Diagnostic Devices - IVDD 98/79/EC

Active implantable medical device means 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;

Active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

In viro diagnostic medical device means 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.

"1. Class I : Low Risk Level -- Non-invasive -- less than 1 hour"

"2. Class IIa : Medium Risk level -- Invasive -- 1 hour to 30 days"

"3. Class IIb : Medium Risk Potentiel -- Implantable -- more than 30 days"

"4. Class III : High Risk Level -- Central circulary system, Central nervous system, Device incorporating a medicinal product, or animal tissue"

"Environment, destination and intended use are determinant for the classification of a medical device."

The involvement of a Notified Body(NB) is not necessary for medical devices of class I uncess they have measuring function or are placed on the market in a sterile condition.

"1. Class I : FDA Product Registration - Minimum Risk -- Non-sterile -- Common -- approx. 14 days"

Class I Medical Devices Examples: These include: Tongue depressors, casters, traditional stethoscope, wheelchair, otoscopes, therapeutic oxygen tanks, inspection gloves, hammertoe calipers, simple devices to facilitate venous access, etc. "EZ vein" a simple class I device had fastest FDA regulatory approval in history (for non-expedited devices).

"2. Class II : Pre-Market Notification - (510(k) - Moderate risk -- SW, FW -- Diagnosis -- upto 30 days"

Class II Medical Devices Examples: These include: digital glucometers, monitor vital signs, anti-bacterial keyboards for hospital use machines in-vitro diagnostic, non-invasive electro stimulators, pathological culture materials, electrical surgical instruments and / o measurement, non-invasive meter hemoglobin (Masimo), ultrasound and endoscope machine.

"3. Class III : Pre-Market Approval(PMA) - High Risk -- Implantable -- Storng Energy Delivery -- more than 30 days"

Class III Medical Devices Examples: They include implantable pacemakers, breast implants, metal hip prostheses, artificail ventricles, tricuspid valve replacements, artificial knee implants, aortic stnts and gamma knife devices.