On to the IVDR: A Paradigm Shift in Diagnostics Regulation is Coming, Ready or Not

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ARTICLE SUMMARY:

Set to take effect in May 2022, the EU IVD Regulation has played second fiddle to the Medical Device Regulation in terms of public focus. But no more. The transition challenge is in many ways steeper for IVDR than it is for MDR, and anxiety levels about system readiness are intensifying. IVDR represents a paradigm shift for diagnostics makers in terms of data and process expectations in Europe. Here’s a look at where things stand and what to expect.

The EU IVD Regulation has been overshadowed by the attention and angst directed at the Medical Device Regulation in the past several years, but growing urgency about the diagnostics regulatory revamp is now clearly breaking through.

Set to take effect in May 2022, there would still seem to be a sufficient cushion of time to support implementation. But key stakeholders say it may already be too late for an on-time successful transition from the current IVD Directive to the IVDR, pointing to the vast amount of preparation still left to be done and the ongoing pandemic that has had a unique impact on the IVD industry due to the testing demands.

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