ARTICLE SUMMARY:
We highlight four important documents issued in October to address the fundamental issue of device/diagnostic risk classification in Europe, the US, China, and Australia.
Docs of the Month is a regular column highlighting key findings from Pathway’s 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.
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More than just about anything else, modern medical device regulation relies on consistent and understandable approaches to risk classification. Placing devices into distinct risk-based classes is the only way for such a diverse universe of products, ranging from stethoscopes to implantable brain stimulators, to fit within the same regulatory system, as we noted last month in Pathways’ Picks. Better establishing the rules of the road for device classifications turned out to be an important focus in October, with four key documents issued in Europe, the US, China, and Australia, as captured by Document Depot:
