Medical Device Classification
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Definition of a Medical Device
Medical devices fall into three major categories, active medical devices, non-active medical devices and in vitro diagnostic medical devices:
- The normative requirements for active medical devices, which include Medical Electrical Equipment, are documented under the IEC 60601 standards family and include the requirements for accessing many global markets under Medical Device Directive (MDD) 93/42/EEC.
- The normative requirements for active in vitro diagnostic medical devices, documented under IEC 61010 standards family form the basis of compliance for most global markets under the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC.
Medical Device Directive 93/42/EEC
The Medical Device Directive 93/42/EEC defines a "Medical Device" as any instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software 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
The Medical Device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
In Vitro Diagnostic Medical Devices Directive 98/79/EC
The In Vitro Diagnostic Medical Devices Directive 98/79/EC defines an "in vitro diagnostic medical device’ 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 (for one of):
- Concerning a physiological or pathological state
- Concerning a congenital abnormality
- To determine the safety and compatibility with potential recipients
- To monitor therapeutic measures.
In addition, specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, 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.
Medical Device Classification
Medical devices vary according to their intended use and indications. Examples range from tongue depressors, medical thermometers and disposable gloves to complex high-tech devices.
Medical devices also include in vitro diagnostic products, such as general purpose lab equipment, reagents and test kits.
Some electronic radiation emitting products with medical application and claims also meet the definition of a medical device with examples including diagnostic ultrasound products, x-ray machines and medical lasers.
Medical device classification based on risk
In accordance with the European Medical Device Directive 93/42/EEC:
- Class I = Low risk
- Class Im (measuring device) = Low risk
- Class Is (sterile device) = Low risk
- Class IIa = Medium risk
- Class IIb = Medium to high risk
- Class III = High risk
In vitro diagnostic medical device classification in accordance with Directive 98/79/EC, is based on grouping of products based on disease or status to be diagnosed:
- List A devices = Blood group determination ABO system, rhesus anti-cell; HIV infection; HTLV I and II; hepatitis B, C and D; Creutzfeldt-Jakob disease (Notified Body conformity assessment is required)
- List B devices = blood groups: anti-Duffy and anti-Kidd; anti-erythrocytic antibodies; congenital infections: rubella and toxoplasmosis; hereditary disease: phenylketonuria; human infections: cytomegalovirus and chlamydia; HLA tissue group determination; tumoral marker PSA; risk of trisomy 21; blood sugar measurement (Notified Body conformity assessment is required)
- Devices for self-testing = based on the technology used, such as immunology or clinical chemistry. Examples of such products include at-home pregnancy and ovulation test kits (Notified Body conformity assessment is required)
- All other IVD devices.
Medical electrical equipment
Medical Electrical Equipment is an active medical device, whose function relies 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.
Eurofins E&E offers regulatory compliance services for active and non-active medical devices and medical electrical equipment through our global network of accredited test laboratories, certification and Notified Bodies. For more information please contact to your local E&E laboratory.Get a quote