Docs of the Year: Five Cross-Cutting Issues from 2021

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ARTICLE SUMMARY:

The total medtech regulatory and policy work product from 2021 is wrapped up in the more than 700 guidances, regulations, pieces of legislation, white papers, and other medtech policy missives published globally and captured in Pathways’ Document Depot. Here’s a spotlight of five cross-cutting topics that attracted significant attention from authorities last year across the globe: COVID-19, risk classification, IVDs, AI/ML, and unique device identification.

This column highlights key 2021 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, nongovernmental groups, and global organizations. 

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Government agencies and partner organizations from around the world were busy last year responding to the pandemic while maintaining and advancing broader authorities tied to medtech. That translated into more than 700 documents last year addressing an array of policy topics, ranging from ones that are very targeted in focus to those that will have an impact for the broader sweep of the industry (see infographic).

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