TÜV Rheinland LGA Products GmbH is Notified Body for the EU Regulation on In Vitro Diagnostics (IVDR) 2017/746. “We are currently one of the few Notified Bodies worldwide for the new IVDR,” says Dr. Wilma Hartung, Managing Director Medical Devices at TÜV Rheinland. The IVDR regulation will replace the currently valid IVD Directive (98/79/EC) from 26 May 2022. The new regulation redefines the system for classifying products fundamentally. Manufacturers must now involve a Notified Body in the conformity assessment for a much larger number of in-vitro diagnostics. Information on the notification is available on the NANDO website of the European Union. NANDO stands for “New Approach Notified and Designated Organisations”.
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.
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.
