ARTICLE SUMMARY:
Nobody has read in full all 560 guidances, regulations, technology assessments, white papers, and other medtech policy missives captured last year in Pathways’ Document Depot. But we’ve looked at a good number of them. Here are a few of our key takeaways from the global slate of 2023 medtech policy documents.
This column highlights 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.
Since we launched Document Depot in May 2020, it has logged upwards of 2,340 documents (and counting) addressing the full gamut of regulatory- and reimbursement-related medtech issues. The primary purpose of the database is to serve as a resource for tracking down specific documents or keeping general tabs on activities from agencies around the world. But there is also some value in mining the growing list of policy documents for cross-cutting trends, hot topics, or other interesting points of fact.
With the new year upon us, we looked through the 2023 list of 560 documents for some of those types of takeaways. This is not meant to be a list of the “top” or most important documents of 2023. We are already covering the implications of the major items—for example, FDA’s September laboratory developed test (LDT) proposed rule or Europe’s March regulation stretching out Medical Device Regulation transition times—elsewhere in Market Pathways. Instead, following our annual Global Policy Docs infographic below, are eight noteworthy themes or under-the-radar points we identified from the broader set of 2023 documents.
