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.
Armin Ritzhaupt, scientific advisor at the European Medicines Agency, noted the “many headaches” looming for products that involve both medicines and devices or IVDs, such as combination products and companion diagnostics.
While Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD, praised the, “steady stream of public documents” released by the European Commission and the Medical Device Coordinating Group (MDCG) in recent months, she said that industry and notified bodies are still missing key guidance necessary to do their jobs.
Hoekstra-van den Bosch added that it is reassuring to hear that the Eudamed actor registration module will be available by the end of the year but questioned whether there will be enough time for implementation by stakeholders. (RELATED: Eudamed actor registration module set to launch in December, Regulatory Focus 19 August 2020).
Auclair said he is worried the delayed rollout of Eudamed could prompt some member states to create or expand national databases that are not compatible with Eudamed, creating a double registration burden for industry, but said he was reassured by the last notice he has seen from the European Commission.
Oliver Bisazza, director of regulations and industrial policy at Medtech Europe, also chimed in, saying the recent MDCG position paper, “Is very, very good, but it still seems to leave open the door for individual countries to maintain national registration requirements, for instance for manufacturers and authorized representatives.”
“We really, really want to know, as soon as the competent authorities can tell us, exactly who is prepared to accept a Eudamed registration in lieu of national ones, because that’s the signal many companies need to actually go ahead and do this voluntary registration early next year,” he added.
Erica Conway, global head of in vitro diagnostic medical devices at BSI, said that one of her biggest concerns is whether, “We have the resources and the hands available that have the right competence to meet the demands of next year before the date of application of May 2022 for the IVDR.”
Conway added that because 80-90% of diagnostics marketed in the EU are self-declared, notified bodies do not know exactly how much demand for certification there will be before the date of application for IVDR and what competencies will need to be represented among their staff.
Bisazza repeated Medtech Europe’s call to delay IVDR due to the COVID-19 pandemic. “It’s becoming increasingly clear that a Plan B will be needed for the IVDR,” he said, noting that it is, “No longer just us, the regulated industry, who is openly expressing concerns about the transition status.”
However, as de Vries noted earlier in the session, “In the regulatory context, the corona[virus] crisis more than anything shows the need for stricter regulation,” noting the influx of rapid and at-home diagnostics imported into the EU amid the pandemic.
For the time being, Sue Spencer, IVD lead and principal consultant at Qserve Group, recommended that IVD makers, “Get a file ready as soon as possible, and make sure [to] have a barometer check. Get it in to the notified body, get the feedback, because you might be shocked at the level of detail that you are expected to have.”
Bassil Akra, CEO of consulting firm QUNIQUE GmbH, added that there are many IVD makers with limited experience with notified bodies. “We have a lot of Class I manufacturers of self-declared devices who have nothing to do with notified bodies … they are going to show up one day and when they show up it will be a big surprise,” he said.
"share" - Google News
September 15, 2020 at 05:22AM
https://ift.tt/3hyDoT3
MDR/IVDR update: Experts share what keeps them up at night - Regulatory Focus
"share" - Google News
https://ift.tt/2VXQsKd
https://ift.tt/3d2Wjnc
Bagikan Berita Ini
0 Response to "MDR/IVDR update: Experts share what keeps them up at night - Regulatory Focus"
Post a Comment