Manoj Gandhi, MD, PhD, is the senior medical director for the genetic testing solutions business at Thermo Fisher Scientific, and is part of the team that provides medical strategy, medical and scientific oversight for product development, on-market product support, and customer engagement.
On May 26, the 1998 In Vitro Diagnostic Directive (IVDD) will become obsolete after a five-year transition to the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) process. The new regulation will impose additional requirements on device and equipment manufacturers to make sure their diagnostics and medical tools perform as intended. These new rules will provide additional oversight over the diagnostics industry, helping to ensure the safety, efficacy, and quality of the products used to improve patients’ lives and efficiency in the lab.
With that five-year transition, the medical devices and diagnostics industry has had time to adapt and prepare for the new regulation and many have already made necessary adjustments to ensure they are compliant. Adherence to the new guidelines is not only important in the interest of following the latest laws, but also to be sure that all companies and manufacturers are providing the highest quality products possible. Thousands across the EU, and the world, rely daily on accurate and effective medical devices, tools and kits, and regulations like the IVDR help to make sure that reliance is not misplaced.
According to the IVDR, all devices and tools will be categorized from Class A to D based on their risk profile, each with a different stipulation on how and when they’re able to be sold. These changes were underway even before the COVID-19 pandemic, a time when the worldwide community was increasingly reliant on accurate and efficient testing kits. Under these new rules, tests for COVID-19 are Class D products, requiring notified body reviews and approvals to be available for marketing and sale, in contrast to past self-applied CE-IVD marks.
|IVDR||Class A||Class B||Class C||Class D|
|Products in classification||Products, which include culture media, specimen receptacles, and other general lab products||Clinical chemistry assays, urine-based tests, and more||Neonatal screening, cancer markers, companion diagnostics, and more||COVID-19, Hepatitis B and C, HIV 1/2, syphilis, and more|
|Rules||Self-certified by manufacturer (except sterile), who applies the CE-IVD mark. Sterile products need notified body review and approval|
Class B, C, and D products need notified body review for approval
Lab managers and practitioners likely won’t notice a difference in the tools and devices they use; the responsibility for abiding to these new rules falls, primarily, on the developers. However, it’s important that those in charge of purchasing lab products stay up-to-date on their equipment and tools by working with their partner manufacturers and developers to figure out their plans for adapting to the upcoming regulation.
Similarly, manufacturers have an obligation to make information easy to access for their partners in the lab. Transparency on their plans pre- and post-deadline helps keep everyone compliant during a time of change. Working together, regulators, developers, clinicians and technicians can create an environment that improves the quality of care by making sure doctors and patients have the best, safest, and most effective tools possible.