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?
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.
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.
New regulation for in vitro diagnostic medical devices: