A lot to be done until the IVDR becomes effective
“By the time enforcement of the new regulation will begin in May 2022, the Notified Bodies will have to test a large number of in-vitro diagnostics manufacturers that are to be certified for the first time and with them a flood of technical documentation,” explains Dr. Hartung. “Even if the year 2022 still seems a long way off, we have already learned with the European Medical Device Directive MDR that manufacturers must adapt to the new requirements at a very early stage. This includes the early involvement of a Notified Body for the IVDR”.
With almost 40 years of experience in in-vitro diagnostic device assessments, TÜV Rheinland is one of the most trusted independent testing service providers for major global brands. More information is available at www.tuv.com/en/IVDR at TÜV Rheinland.