Non-Active Medical Device Testing

The GM mark (Geprueftes Medizinprodukt) is a certification confirming that your product meets a globally recognized standard in the areas of quality, safety and manufacturing. Securing the GM mark also demonstrates your intention as a reputable merchant.

Non-active medical devices (Class I) are not required to adhere to the strict quality testing imposed on active medical devices. This means there is a much lower barrier-to-entry into the market. While this may seem advantageous, the challenge of achieving differentiation becomes more difficult.

Securing quality certifications such as the GM mark proves your products go beyond the mandated regulations and your commitment to excellence.

Demonstrate quality with the GM mark and extend your market access!

Today, a wide variety of medical devices are receiving a lot of attention with particular focus on their quality. The internationally respected GM mark validates the exceptional quality of your non-active medical devices.

• 1. Qualification
  We review technical documentation and conduct product testing in our accredited laboratories. A passing result must be achieved to move forward in the process.
• 2. Site inspection
  Our experts conduct a thorough on-site factory inspection.
• 3. Certification
  Successful candidates receive our quality seal and a unique QR code identification.

Preparing for your GM mark assessment is similar to most certification processes. It is an opportunity for you to review your processes, workflows, production and documentation with great scrutiny.

Our experts thoroughly review your technical documents and your product will endure a series of tests. Once a passing result is achieved, an on-site factory inspection will be scheduled. A successful evaluation and final result will be conferred an official findings report and a unique identifier... The identifier references a unique quality seal, a dedicated Certipedia listing, and a corresponding QR code that can be scanned by customers around the world.

Securing a GM mark differentiates you from market competitors, showcases your quality manufacturing and creates a foundation of best practices for future business expansion.

We are a Notified Body for medical device auditing with an expansive network of accredited testing laboratories around the world. With nearly 150 years of industry leadership, in-house experts, market access knowledge and end-to-end services, we deliver timely, quality results that translate directly into increasing your capabilities in the medical device market. Our comprehensive services across a wide range of industries and scope makes us the preferred choice of the world’s most recognized brands.

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
• FORA 6 Connect - Foracare
• EasyMax® M/J – EPS Bio Technology Corp.