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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 126 KB Download

More information

Unannounced audits

Approved blood glucose meters

Picture Gallery

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Approved blood glucose meters

Millions of people worldwide have diabetes. Today, these people can control their disease and effectively prohibit the risk of complications on their health with an accurately functioning Blood Glucose Monitor (BGM) and insulin pen injector.

TÜV Rheinland Nederland is the leading institute for testing BGMs and pen injector systems. We perform tests for manufacturers in conformity with all relevant and most actual standards and in compliance with the European medical devices directives in accordance with the TÜV Rheinland Guideline for BGMs the ISO 11608-1 and ISO 15197.

At the same time we offer the flexibility to perform additional tests apart from the standards according to your needs of needs of the market. We test all sorts of pen injectors, for example with and without electronics, with replaceable needles, none- replaceable, electronically driven.

TÜV Rheinland has a set test protocol and testmark programme for blood glucose meters dat perfectly fits with the market need for continuous quality control. BGMs that comply to these standards get the TÜV Rheinland certicate en get the TÜV Rheinland testmark. TÜV Rheinland retests yearly.

The approved BGMs are listed below:

  • Cellnovo Aviva Handset, Cellnovo
  • CareSens Dual, (distributor Zkope Healthcare)
  • CareSens N, I-Sense (distributor Zkope Healthcare)
  • CareSens N POP, I-Sense, (distributor Zkope Healthcare)
  • CareSens N Premier, (distributor Zkope Healthcare)
  • Diatesse XPER (TD-4289B) - GD Medical Pharma BV
  • FreeStyle Freedom Lite, Abbott
  • FreeStyle InsuLinx, Abbott
  • FreeStyle Libre, Abbott (only the internal measurer, not the Flash-monitoring system)
  • Glucomen LX Plus, A.Menarini Diagnostics
  • GlucoMen Ready, A.Menarini Diagnostics
  • Glucofix Tech, A.Menarini Diagnostics
  • Glucofix Tech 2k, A.Menarini Diagnostics
  • HT One Lumina OK-14V, GD Medical Pharma BV
  • HT One TD Gluco - GD Medical Pharma BV
  • HT One TD Gluco Bluetooth (TD-4277B) - GD Medical Pharma BV
  • mylife Unio - Ypsomed Distribution AG
  • mylife Unio Neva - Ypsomed Distribution AG

Downloads

pdf Wireless in Medical Environment - Evaluation of Wireless Technology 1 MB Download
pdf Flyer BGM and pen injector testing 144 KB Download

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