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IVDR Certification

Our Expertise for Your Successful Market Entry in Europe

In vitro diagnostic medical devices (IVD) are used to analyze human body samples for medical purposes. The term covers products as diverse as reagents, calibration materials, control materials, kits, instruments, systems and software. The results of tests where IVDs are used influence medical decisions directly affecting patient wellbeing therefore, the safety and reliability of these medical devices is of particular importance.

Since 1998, in vitro diagnostic medical devices have been regulated by Directive 98/79/EC. On May 25, 2017, the new EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) 2017/746 came into force, placing more extensive requirements on IVD and their manufacturers. Following a five-year transition period, products must meet the requirements of the IVDR in order to receive the CE mark and be allowed to enter the European market. (A longer transition period applies to a few exceptions.) It is noteworthy that CE marking provides a competitive advantage in many markets worldwide.

As one of currently five Notified Bodies worldwide (status: November 19, 2020), we offer services throughout your transition to the new IVDR. As a single source provider with a comprehensive range of medical testing and certification services, we can offer you a customized service tailored to your specific products and needs.

You want to learn more about our services related to the IVDR?

Transition Period for the EU Regulation IVDR 2017/746 | TÜV Rheinland

Transition Period for the EU Regulation IVDR 2017/746 | TÜV Rheinland

All IVDR Services

With 40 years of experience as a provider of testing services for the safety and quality of in vitro diagnostic medical devices (IVD), we are a competent partner for transitioning to the IVDR. In addition, we support manufacturers of IVD and medical devices with market access services into the European and international markets.

Regulation on In Vitro Diagnostic Medical Devices (IVDR)

Regulation on In Vitro Diagnostic Medical Devices (IVDR)

As one of five Notified Bodies in Europe, we are a trusted partner for the transition to the IVDR.

Assessment and Certification of Companion Diagnostics

Assessment and Certification of Companion Diagnostics

In the future, our experts will also assess the conformity of companion diagnostics (CDx) with the new Regulation on In Vitro Diagnostic Medical Devices (IVDR 2017/746).

Testing, Assessment and Certification of In Vitro Diagnostic Medical Devices

Testing, Assessment and Certification of In Vitro Diagnostic Medical Devices

The IVDR is changing the conditions for bringing in vitro diagnostic medical devices to the market in the EU. Use this transition period to prepare yourself for a certification based on the new regulation.

Do you have any questions about the IVDR?

With our experience as Notified Body with the certification of in vitro diagnostic medical devices, we support you during the transition from the IVD Directive to the IVDR with meeting deadlines and with many other aspects that are relevant for your products to enter the European market.

Here, we have summarized the most important questions and answers for you.

Webinar „IVDR Basics & Transition Tips“

In vitro diagnostic medical devices (IVD) are used to analyze human body samples for medical purposes. The term covers products as diverse as reagents, calibration materials, control materials, kits, instruments, systems and software. As one of currently five Notified Bodies worldwide (status: November 19, 2020), we offer services throughout your transition to the new IVDR. In our webinar, you will receive basic information on the changeover to the new directive.

Questionnaires and application documents for certification according to IVDR

Further Information

New regulation for in vitro diagnostic medical devices:

Regulation on In Vitro Diagnostic Medical Devices EU 2017/746

Declaration of Interests MDR / IVDR

Learn more about our services related to the IVDR.

Learn more about our services related to the IVDR.

We will provide you with a non-binding offer