The designation of this organization means there are now four notified bodies under the In Vitro Diagnostics Regulation (IVDR).
Those who have previously gained notified body approval under IVDR include: DEKRA Certification, BSI Assurance UK, and BSI Group The Netherlands.
IVDR came in to force in 2017, and products which are already approved must be recertified by 26th May 2022. IVDR regulates market access for in vitro diagnostic medical devices on the European market. This regulation will replace the EU’s current directive on in vitro diagnostic medical devices.
Andreas Stange, vice president medical and health services, TÜV SÜD, said: “We are excited about our designation as notified body.” He explained how, “in recent months we have expanded our team throughout the world, to deliver comprehensive IVDR activities”, and added, “unless already done, manufacturers of in-vitro diagnostics should get ready for the IVDR immediately to avoid bottlenecks in the testing and certification of their devices.”