IVDR in Europe for 2022 faces several challenges

CIO Review Europe | Sunday, February 21, 2021

The EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) will fundamentally change how the IVD sector in Europe operates

FREMONT, CA: While the vote to formalize the European Union's (EU) progressive rollout of the upcoming In Vitro Diagnostic Medical Devices Regulation (IVDR) came in December, the race to prepare all stakeholders for the sweeping new set of regulations for this year is underway. The European Commission has released its Joint Implementation Plan, which identifies high-priority activities that the EU must do to meet the challenge of implementing IVDR by the deadline of May 26 – but significant gaps remain.

Even without the added obstacles that a worldwide pandemic has brought to everyday business, the EU's task is enormous. The IVDR introduces significant changes to the in vitro diagnostics, including a completely new device classification system, the establishment of EU reference laboratories for assessing the conformity of high-risk Class D devices, and a significant increase in the involvement of Notified Bodies in IVD conformity assessment and post-market surveillance.

These developments have alarmed industry stakeholders, leading to an overwhelming majority vote of 687 to six in December to postpone IVDR certification dates. Only six Notified Bodies have been certified to issue IVDR compliance certifications so far, compared to 18 under the last set of IVD laws. With the proposal noting that about 80-90 percent of IVD devices will require assessment owing to devise re-classification under IVDR, demand for Notified Body involvement is likely to far outstrip capacity for granting new certifications. While the gradual implementation of IVDR would allow many CE-marked devices to stay on the market, for the time being, many IVD device certifications are set to expire in 2024. Only 31 IVD devices had achieved IVDR certification as of last year. With IVDR reviews taking nine to eleven months from the moment an application is received, the backlog is unlikely to be cleared anytime soon.

While the Commission's strategy claims that significant progress toward IVDR adoption has been made, it also identifies blind spots that could jeopardise IVDR acceptance this spring. It claims that a lack of data on the number of new IVDR certificates poses a considerable risk to forecasting the capacity required for Notified Bodies to satisfy demand in the future. As a result, the Commission recommends that an intensive market monitoring exercise be included as part of the strategy. Member states and relevant authorities must collect quantitative data from the industry regularly to make reliable preparedness assessments.

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