Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as the date of application for both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach.
With MDR delayed to May 2021, and with Eudamed’s full rollout and the IVDR date of application seemingly on track for May 2022, regulators, industry and notified bodies have much to prepare for in the coming months, with the coronavirus disease (COVID-19) pandemic adding significant complication to those efforts. (RELATED: Eudamed to launch in 2022 for both devices and IVDs, Regulatory Focus 30 October 2019; MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020).
Philippe Auclair, senior director of regulatory strategy EMEA at Abbott, pointed out that while MDR was delayed by a year, the grace period for placing devices on the market under the current directives remains unchanged.
“Yes, now we have an additional year, well, an additional eight months remaining, but this also means that the grace period has been contracted from four years to three years,” Auclair said.
Laura de Vries, coordinating/specialist inspector at the Dutch Health and Youth Care Inspectorate, told the audience that competent authorities, “See and recognize the problems regarding notified bodies, both with regard to their designation and the fact that they cannot perform on-site audits for MDR certification,” due to COVID-19.
Her advice was for industry and notified bodies to “do as much work as possible off-site,” which is something her agency is trying to do as well…