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GM Mark
This voluntary test mark shows compliance of a medical product with the essential requirements of the Medical Device Directive (93/42/EEC), the Active Implantables Medical Directive (90/385/EEC) or the In Vitro Diagnostics Directive (98/79/EC).
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 including dressing material or surgical gloves and in-vitro diagnostic equipment.