While the vote to formalise the progressive rollout of the looming In Vitro Diagnostic Medical Devices Regulation (IVDR) for the European Union (EU) came in December, the race to prepare all stakeholders for this year’s implementation of the sweeping new set of regulations is on. The European Commission has published its Joint Implementation Plan on high-priority actions required for the EU to rise to the challenge of implementing IVDR ahead of the 26 May deadline – and significant gaps remain.
The task ahead of the EU is daunting, even without the complications that a global pandemic has brought to conducting ordinary business. IVDR brings with it fundamental changes to the way the in vitro diagnostics sector will operate, including an entirely new device classification system, the establishment of EU reference laboratories for assessing the conformity of high-risk Class D devices, and substantially more involvement from Notified Bodies in assessing IVD conformity assessment and post-market surveillance.
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These changes have led industry stakeholders to express their concern, ultimately leading to December’s overwhelming majority vote of 687 to six to delay IVDR certification deadlines. To date, only six Notified Bodies have been certified to issue IVDR compliance certificates, a far cry from the 18 that operated under the prior set of IVD regulations. Demand for Notified Body participation is expected to greatly outpace capacity for issuing new certificates, with the plan acknowledging that roughly 80-90% of IVD devices will require assessment due to device re-classification under IVDR. While the progressive rollout of IVDR will allow many CE-marked devices to remain on the market for now, the certifications for many IVD devices are set to expire in 2024. As of last year, only 31 IVD devices had received IVDR certification. With IVDR reviews required nine to 11 months after the receipt of an application, the backlog is not expected to clear any time soon.
While the Commission’s plan states that significant progress towards IVDR adoption has been achieved, the plan lays out blind spots that threaten the timely adoption of IVDR for this spring. It states that an absence of information surrounding the number of new IVDR certifications needed poses a significant risk to predicting the capacity required for Notified Bodies to meet demand moving forward. For this reason, the Commission is recommending an intensive market monitoring exercise as an essential component of the plan. Member states and competent authorities are to regularly collect quantitative data from industry to make robust preparedness estimates. By way of MedTechEurope’s September 2021 Survey Report, less than half of IVD manufacturers had entered into a contractual agreement with a Notified Body to assess and certify IVDs and their quality management systems.
The newly published implementation plan calls on the European Commission to further consider how Notified Bodies can perform conformity assessment activities under the circumstances of the pandemic, and for discussion among EU Member States on how to increase Notified Body capacity. The document further suggests that stakeholders will have to ‘manage some uncertainty in areas where guidance is not available’. This will come as discouraging news to Notified Bodies, which recently admonished regulators via the Team-NB stakeholder group’s position paper published in December. In the paper, numerous concerns were raised regarding a lack of clarity around guidelines for conducting remote audits. Last year, regulators passed an adoption that would allow Notified Bodies to conduct portions of conformity assessments remotely for clinically necessary devices at risk of a shortage. In the event, fewer than 5% of such IVDR audits were conducted, with Team-NB citing the need for clear instruction on what constitutes a true risk of shortage.
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The plan comes as the result of a review by the Medical Device Coordination Group with input from its relevant sub-groups and various stakeholders. Moving forward, the plan will serve as a living document to monitor progress towards IVDR implementation, with the status and timelines for each recommendation to be updated as the situation unfolds.
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