EU IVD Reg Pressures Come to a Head

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The EU IVD Regulation has been overshadowed by the attention and angst directed at the Medical Device Regulation in the past several years, but growing urgency about the diagnostics regulatory revamp is clearly now breaking through.

There were two important bits of news in the past week tied to the oncoming IVDR. One was a positive update: TÜV Rheinland became the fifth and latest notified body to be IVDR-designated, adding one more place for companies to go to achieve CE marks under the new regulation. The other development puts a less rosy frame on that news: EU’s notified bodies signaled that if significantly more notified bodies are not designated and other implementation steps are not addressed by year’s end, IVDR implementation delays will be needed to avoid major sector disruptions.

While the EU MDR is bringing a significant shift in regulatory scrutiny for devices, the IVDR in many ways has always represented an even bigger transition for diagnostics. Both MDR and IVDR were signed into law in 2017, but policymakers granted an extra two years of transition for the IVD Regulation, recognizing that it is fundamentally upending regulatory oversight in the space. The current IVD Directive (IVDD) features a limited “positive list” specifying which tests must undergo notified body review, accounting for less than 10% of tests. The IVDR switches to a more globally harmonized risk-based classification system that will result in more than 80% of tests requiring notified body oversight. That shift will require a massive change in manufacturers’ mindsets and ramp-up in notified body resources.

But since 2017, the pace of notified body designations and release of implementing documents for the IVDR has been lethargic, and a global pandemic that has required massive attention by the diagnostics community has hit. With 18 months to go until the May 2022 IVDR go-live date, explicit calls for a pressure-valve release are escalating. The device industry stepped up its overtures last month, and now the notified body sector is joining in.

TEAM-NB, the trade group representing EU notified bodies, issued a position paper November 25 laying out two conditions it believes need to be met by the end of 2020 for the current IVDR transition timeline to be feasible. 

First, the group says, “tools necessary to perform conformity assessments” must be available. This includes publishing “Common Specifications” that will form the basis of high-risk IVD conformity assessments, the formation of EU reference laboratories and centralized EU expert panels, and the release of all relevant guidance documents. Second, TEAM-NB says, at least half of the 22 notified bodies that are currently designated under the IVD Directive should be designated under the IVDR.

“If these conditions cannot be met, notified bodies recommend a decision regarding the [IVDR date of application] is taken by the end of 2020 at the very latest to minimize the impact on the IVD market and stakeholders,” the position paper states.

Both of these milestones are very tall orders for EU policymakers to meet in December, particularly the notified body designations. TÜV Rheinland was formally added as the fifth IVDR designee on November 27, five months after the most recent prior designation, of fellow German body TÜV SÜD, was made. European Commission data suggests six more designations (to reach TEAM-NB’s goal of at least 11) is not in the offing in the next month.

The bodies that have been designated all have been authorized to perform assessments on most or all IVD product types, which experts say is good news. But one of the five designees is the UK-based entity of BSI, which will not be able to maintain its EU IVDR status once Brexit goes ahead in 2021. The volume of conformity assessment work that notified bodies will have is expected to mushroom under the IVDR compared to the IVDD. And it is particularly noteworthy that the extent of what the increase will be is still unknown, making it so the bodies that have been designated or are close to that milestone can’t properly plan investments in the space.

“There's probably still a lot of companies in transit, in that transition mode, who haven't started the assessment process. And if they have a large portfolio of products, that's a bit scary,” Robyn Meurant, an Executive Director at NSF International and IVD expert, explained in an interview. “Knowing how deep that iceberg is that's sitting there is a really interesting question.”

If the Commission doesn’t meet TEAM-NB’s conditions, the notified body group says policymakers should take one of two actions by the end of this year, drawing from steps that the Commission has taken in response to pressures on the MDR.

The first alternative, according to TEAM-NB, is expanding the existing IVDR grace period to cover more products. Similar to the MDR, companies that have a notified body-signed-off certificate gained via the IVDD before May 26, 2022, can continue to market the test under the Directive through 2024 or until the certificate expires. For the MDR, policymakers realized that a subset of devices that were being upclassified from the Directives to the MDR into notified body status were under outsized pressure, and they ultimately agreed to expand the MDR grace period to include those products. Notified bodies now want the EU to take a similar step for the IVDR, where the proportion of products that are flipping from non-NB to NB status is much greater.

Specifically, the request is to expand the grace period to cover Class A (low risk) and B (low/moderate risk) devices that will newly require notified body review under IVDR. “This option would allow all stakeholders to focus on the timely implementation of the IVDR for high- and medium-risk devices in particular,” the notified bodies state.

This alternative could likely be facilitated by the EU Medical Device Coordination Group’s recently issued and long-awaited guidance on IVDR classification rules. That document formalizes manufacturers’ ability to document the proper classification of their products to determine if they would qualify for the expanded grace period.

But still missing, according to TEAM-NB, are the common specifications and EU reference laboratories that will be necessary to complete IVDR conformity assessments of high-risk Class D devices. In the absence of those within the next month, notified bodies favor a broader postponement from the May 2022 IVDR date of application, similar to the one-year delay recently granted for the MDR (to May 2022) on response to COVID-19 challenges.

“The continued travel restrictions caused by the COVID-19 pandemic delay the completion of onsite initial IVDR and MDR audits with the risk of an audit ‘congestion’ in 2021,” TEAM-NB says.

EU officials have been extremely reticent to even publicly consider an IVDR delay, pointing to the MDR decision as a one-off action taken amid the extreme pressures of the early days of the pandemic. While industry points to COVID-19, which has challenged the IVD industry more than most, as a key factor driving the need for some additional leeway or a postponement on IVDR, EU officials say the pandemic underscores why the new regulation is needed as soon as possible.

Companies can self-declare COVID-19 tests under the IVDD, but, according to the new classifications guidance, SARS-CoV-2 assays will be Class D under the IVDR, requiring a full conformity assessment including reference lab testing.“We are really lagging behind the rest of the developed world on this,” Erik Hansson, deputy head of the medical device unit within the European Commission’s health division (DG-SANTE), said last month. “Politically, I think the odds for having a postponement are very low.”