| This voluntary test mark shows
compliance of a medical product with the essential requirements
of the Medical
Device Directive (93/42/EWG), the Active Implantables Medical
Directive (90/385/EWG) or the In Vitro Diagnostics Directive (98/79/EEC).
Assessment of the product is performed according to harmonized,
international or national standards or according to criteria determined
in cooperation with the manufacturer. The manufacturing process
is monitored within TÜV Rheinland's Factory Inspection Scheme.
The license issued for the GM mark displays the following information
for both the manufacturer and the consumer:
· Applied
standards (e.g. EN60601 general, collateral and particular
standards)
· Reference
to Annex I of the MDD, AIMD or the IVDD
· Universal
Medical Device Nomenclature Code
· Device
Name and Type Designations
 · Classification
of the Device (e.g. MDD Class I, Protection Class I, Type B)
 · Specifications
(e.g. ratings, features)
The GM mark is available for all medical devices such as diagnostic
and treatment equipment, active implants, medical disposables
such as dressing material or surgical gloves and in-vitro diagnostic
equipment.
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