Docs of the Month: EU IVDR, India Drive Diagnostic Policymaking

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ARTICLE SUMMARY:

Of the 72 global medtech policy documents captured by Document Depot in July and August, almost 20% addressed in vitro diagnostics, including an acceleration of IVD Regulation implementing items in Europe, and more from Asia and the US.

Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot,a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.

In vitro diagnostics raise special policy considerations and conundrums compared to the broader medtech product realm, making IVDs a frequent topic for exploration and reconsideration by regulators. It’s not unusual for multiple IVD guidelines, rules, or other documents to roll out each month as agencies around the world work to fine-tune appropriate testing, data, and procedural expectations for lab-test technology.

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