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Posted 01 June 2021 | By Kari Oakes 

Industry and patient groups call for IVDR delay

2928 In the wake of the 26 May EU implementation of the new medical device Regulation (MDR), a trade group, a patient association and a data analytics firm have jointly called for a delay in implementation of the parallel In Vitro Diagnostics Regulation (IVDR), now slated for 26 May 2022. Without a course correction, the organizations cite the potential for serious disruptions in patient care, especially in targeted therapies for cancer patients.
With just a year to go before the date of application of the IVDR, “only four Notified Bodies (NBs) have been designated to date (22 under the previous legislation) whereas the workload to assess diagnostics for NBs is estimated to increase by 600-700% under the new regulation compared to the situation under the existing legislation,” wrote the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Cancer Patient Coalition (ECPC) and Diaceutics in a 26 May press release.
The press release accompanied a joint stakeholder letter addressed to the in vitro diagnostics working group of the European Medicines Agency’s Medical Device Coordination Group. The letter calls for both postponement and a phased approach to IVDR implementation. (RELATED: MDR/IVDR: Commission adopts new standardization request, Regulatory Focus 16 April 2021)
The pandemic has further compounded implementation problems, note the authors of the letter, citing the greatly slowed pace of on-site audits. This, coupled with the fact that over two thirds of small- and medium-sized IVD bodies have not secured a notified body, means trouble inevitably lies ahead, they said: “Even if the infrastructure required to support the transition toward the IVDR were put in place and fully functioning within this year, NBs could not possibly take on and manage this immense workload in such a short period of time to avoid market disruption.”
One potential downstream effect of the current schedule for IVDR application is interrupted access to biomarker testing. A Diaceutics case study estimated that IVDR application in 2022 could mean that up to 65,000 non-small cell lung cancer and ovarian cancer patients yearly would not receive the testing that would allow targeted therapy for their conditions.
In the stakeholder letter, the leaders of EFPIA, ECPC and Diaceutics call for an initial one-year postponement of IVDR application, followed by a phased-in approach that places a priority on NB assessment of “high-risk impact diagnostic tests.” Finally, the letter requests for the pace of NB designation to speed up and for full Eudamed functionality together with “prompt release of key guidance documents.”
When asked, regulatory experts working in the EU concurred that real problems lie ahead if the IVDR rollout continued apace.
If any course adjustments are planned, device manufacturers and NBs should be alerted as soon as possible, commented Sabina Hoekstra-van den Bosch, PharmD, FRAPS, regulatory strategy principal at TÜV SÜD. “As everybody in the sector needs to plan in advance, it would be beneficial if any change of plans is announced early on and not last-minute, as we have seen with the postponement of the MDR date of application,” she said. Although the pandemic contributed to disruptions in MDR rollout, “the lesson is, ‘the earlier, the better,’" said Hoekstra-van den Bosch.
Compared with MDR rollout, “the IVDR is in much worse shape, as all capacity has gone to the MDR,” said Erik Vollebregt, LLM, partner at Amsterdam-based Axon Lawyers in an interview. “I think the authorities need to really step up efforts to avoid that the IVDR implementation is going to be a total train wreck," said Vollebregt, noting that most IVDs have yet to receive assessment by a NB, “which we’ve known for years and years already."
What should device manufacturers in the EU do, assuming the calls for IVDR delay go unheeded? Vollebregt, noting that IVD companies have seemed “quite slow to catch on,” advised “immediate and full attention” to IVDR preparedness. In addition to the findings of the Diaceutics case study, he pointed out that diagnostics have broad impact. "If COVID has taught us one thing it's that IVD tests are important to society."
Gert Bos, PhD, FRAPS, Executive Director and partner at the Netherlands’ Qserve Group EU, was direct, and grimly realistic: “Get the application in today. Do not wait. Do not postpone. And get all the help you can get.”
Stakeholder letter


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Tags: EC, EMA, EU, IVDR, MDCG, oncology

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