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The 6-Step Checklist For IVDR Compliance
By Hilde Viroux and Hans Mische, PA Consulting
The in vitro diagnostic devices industry has until May 25, 2022 to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017 (IVDR). This regulation is a major revision, focusing on patient safety, requiring more clinical evidence, improving traceability in the supply chain, and enforcing a proactive post-market surveillance system to ensure early detection of problems.
The past year presented a challenge in implementing the IVDR while the COVID-19 pandemic forced the industry to focus efforts on bringing COVID-19 tests to the market. The May 2022 deadline is quickly approaching and there is no sign that the EU Commission is considering postponing it. Even if the deadline is pushed back, the expectation is that it would only be for a year, similar to the extension granted for the medical devices regulation. F