Episode 26 – IVDR preparation with Andreas Stange
We talked a lot about the EU MDR, but we should not forgot that there are also a similar change that is happening to the In-vitro Diagnostic Medical Devices with the EU IVDR 2017/746.
Manufacturers should be ready by May 26, 2022 but this will be really a huge work for them. Before only 20% of the products needed a notified body for placing their products on the market. Now with the IVDR it’S 80%.
So how should they prepare for that? Dr. Andreas Stange from TÜV SÜD will be my guest and answer questions about this new regulation. He will provide valuable information for the manufacturers to really focus on their journey to get certified.
Who is Dr. Andreas Stange?
Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia.
Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.
- Andreas Stange LinkedIn Profile: https://www.linkedin.com/in/andreasstange/
- TÜV SÜD notified body: https://www.tuvsud.com/
- IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746