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Tested Medical Device

Tested Medical Device

Market Your Products More Effectively with Voluntary Certification

TÜV Rheinland Tested Medical Device

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 mark 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

Three Steps to a Test 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. Quality Seal
If the certification is successful, you receive a certificate from us.

Which medical devices can carry the "Tested Medical Device" mark?

The "Tested Medical Device" quality mark is issued for medical devices that meet the following criteria:

1. Legal requirements:

  • Successful completed 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

Offer

pdf Your inquiry 24 KB Download
pdf General Terms & Conditions 62 KB Download
pdf Testing & Certification Regulations 120 KB Download

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