Even a six-year transition is pushing the limits of a diagnostics industry sidetracked by the COVID pandemic. Market Pathways’ recently delved into the details of EU IVD Regulation challenge. Here’s a short excerpt from that analysis in the latest Pick of the Week.
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Set to take effect in May 2022, there would still seem to be a sufficient cushion of time to support implementation of the new European In Vitro Diagnostic Regulation. But key stakeholders say it may already be too late for an on-time successful transition from the current IVD Directive to the IVDR, pointing to the vast amount of preparation still left to be done and the ongoing pandemic that has had a unique impact on the IVD industry due to the testing demands.
The plans for the IVDR were laid out in parallel to the MDR, and both were made into law in 2017. But while EU policymakers agreed to a three-year transition period for the MDR (recently extended to four years in the wake of the COVID-19 pandemic), they approved a total of five years for the IVDR implementation process. The reason for the extra time: it’s widely acknowledged that the IVDR transition is more challenging than it is for the MDR. That has a lot to do with the difference in status quo—how medical devices versus in vitro diagnostics are regulated under the current EU directives. Both the MDR and IVDR are anchored by a risk-based classification system that defines the level of requirements and active oversight that products will be subject to. For medical devices, the scheme strengthens the current directives framework, but for IVDs, it represents a paradigm shift.
The current IVD Directive features a “positive list” of the specific test types that must undergo notified body assessment to enter the EU market. Under that approach, upwards of 80% of IVDs can self-declare conformity without a notified body. Under the IVDR risk classification system, the situation will flip—the general expectation is that 80% or more of tests will require notified body pre-market assessment before CE marking, and less than 20% will be able to self-declare. “Actually, that's very conservative,” Steve Lee, a long-time UK government IVD official who is now the director of diagnostics regulation at the British trade association ABHI, tells Market Pathways. “I think it's more like 90-10, or even 95-5.”
No matter the ratio, it represents a massive shift in resource needs in the IVD space—both for the IVD companies who must compile the evidence, standard practices, and planning documents to satisfy notified bodies’ needs under the strict new IVDR requirements, and for the notified bodies themselves whose workload is mushrooming in the build up to the new regulation.
“The five-year transition was always going to be tight because of the number of people in the system,” Lee points out. “I've heard ... for MDR and IVDR, you need an extra 5,000 regulatory affairs professionals in the system to be able to support it. And a lot of that is going to come from IVDs. A small industry with really good people in it, really dedicated people, but actually not enough people to go around.
“The change in notified bodies—95-5—the amount of clinical evidence that's needed, and the number of regulatory affairs professionals that are needed means that actually the five years is just a little bit on the tight side,” he notes. “Add then add COVID-19 into that.” Companies involved in the COVID-19 response “have been under the spotlight and have been focused on what they should be focused on, which is investing in the pandemic, not necessarily IVDR.”
On the manufacturer side, larger companies are making inroads toward IVDR compliance, and the first CE marks under the oncoming regulation started to filter through in the final three months of 2020. But there is a long tail of smaller and mid-sized firms in the IVD space and there are signs that many are not on track to meet the upgraded thresholds for clinical evidence and postmarket planning, among other areas, and to secure needed notified body resources.
Excerpted from “On to the IVDR: A Paradigm Shift in Diagnostics Regulation is Coming, Ready or Not,” Market Pathways, January 21, 2021.
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