- A panel of experts convened by the European Union to evaluate the performance of high-risk in vitro diagnostics has begun accepting applications from notified bodies.
- The panel will provide an additional layer of scrutiny to some high-risk class D diagnostics to confirm they perform as claimed. Until now, notified bodies could accept applications for the IVDs but not issue certificates because of the lack of an operational expert panel.
- While the expert panel is now staffed and accepting applications, there is still work to do to set up the EU reference laboratories (EURLs) that will also scrutinize class D IVDs.
The incoming EU IVD regulation requires that certain diagnostics are subject to review by an expert panel and/or testing by an EURL. The Performance Evaluation Consultation Procedure carried out by the expert panel is the IVD equivalent of the medical device clinical assessments that got underway earlier this year.
The Commission disclosed the opening up of the IVD expert panel for submissions from notified bodies in a very short update that provided no further information. Previous publications from bodies such as the Medical Device Coordination Group have set out the details of the process.
In April, MDCG published information about the transitional provisions for certification of class D IVDs, explaining that notified bodies should submit performance evaluation reports to the expert panel within five days of it becoming operational. The Commission disclosed the opening up of the expert panel for submissions on Sept. 3.
Under IVDR, the expert panel should offer an opinion to the notified body "within the deadline for delivery of the scientific opinion by the EU reference laboratory." However, EURLs remain a work in progress. Implementing acts on EURLs are due this quarter but for now the expert panel is working without lab support. In the absence of EURLs, the panel has 60 days to share its views on a filing.
Based on the timeline and need for notified bodies to submit performance evaluation reports this week, the first opinions could be two months away. The first MDR expert opinion became public around three months after the panel began accepting applications.
Six notified bodies are currently designated under IVDR. There are signs the small group of notified bodies is chipping away at a mountain of work that has caused alarm in the medtech industry. This week, Siemens Healthineers said TÜV Rheinland has certified 129 of its hemostasis and nephelometry IVDs. TÜV Rheinland became the fifth notified body designated under IVDR in November, suggesting it completed the work in under nine months. Healthineers expects "more than 4,000 products to be certified in good time by May 2022."