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.
With TÜV Rheinland's independent test mark, you can:
Our experts certify your medical devices in three steps:
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.
The "Tested Medical Device" quality mark is issued for medical devices that meet the following criteria:
1. Legal requirements:
2. Further criteria that go beyond legal requirements:
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: