In a panel at RAPS’ Euro Convergence, top experts on the EU In Vitro Diagnostic Regulation (IVDR) discussed the state of the industry just 18 months before the regulation’s May 2022 date of application.
Opening the session, Gert Bos, executive director and partner at Qserve Group, laid out the stakes for IVD developers: “Yes, IVRD is different from [the Medical Device Regulation] MDR, the pressure is much higher because there is such a big gap between the current situation, the current legislation and the future legislation. The grace period is nice, but for the majority of the products it is not applicable and as such we will all see the crunch, the pressure, the pain in the next year and a half, but hopefully in a shorter time we have solutions,” Bos said.
Armin Ritzhaupt, scientific administrator at the European Medicines Agency (EMA), discussed some of the unique challenges surrounding companion diagnostics under the regulation and said the lack of guidance in some areas has been a hindrance.
“Who would have thought that three or more years after the adoption we are still talking about where is the guidance, where are some of the other elements we would like to see? And yes, we have been working on them, perhaps with some interruptions,” he said, pointing to Brexit and the COVID-19 pandemic as major disruptions impacting the runup to the regulation.
Tom Patten, certification and inspection officer at the National Standards Authority of Ireland (NSAI), addressed the gap between notified body designed under IVDR compared to the MDR…