Medical Device Certification Mark (GM - Mark)

Market Your Products More Effectively with Voluntary Certification

Buyers, users, and consumers all want the same thing: medical devices that offer a high standard of quality and safety. That's why we developed the "Tested Medical Device" label, our GM mark. This test mark goes above and beyond the standard legal requirements. It includes additional tests, such as a product site inspection and a technical documentation review. Use our GM quality seal to ensure confidence in your products.

Benefits at a Glance

With TÜV Rheinland's independent test mark, you can:

  • Gain a competitive edge over the competition by going above and beyond your legal requirements
  • Offer your customers guidance in choosing your product
  • Enjoy the added trust that comes with certification from a Notified Body
  • Benefit from fast lead times and our long-standing experience

Our Services for 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 such as dressing material or surgical gloves and in-vitro diagnostic equipment.

Three Steps to the GM- Mark for Your Medical Device

Our experts certify your medical devices in three steps:

1. Test
We test your product at our site and review your technical documentation.

2. Site inspection
We inspect your production facility.

3. GM - Mark
If the certification is successful, you receive a certificate from us.

Which medical devices can carry the "Tested Medical Device" GM - Mark?

1. Legal requirements:

  • Successful conformity assessment procedure, ensuring compliance with the relevant medical device directive
  • For medical devices (except class 1): a valid certificate from a notified body

2. Further criteria that go beyond legal requirements:
  • Additional product testing for compliance with uniform standards. If no standards exist, we can select national standards and other test requirements that comply with the medical device directive.
  • Initial product site inspection with regular follow-up inspections
  • Technical documentation review