ARTICLE SUMMARY:
What were the most significant global policy documents published in medtech last year? Here’s Market Pathways’ top 10 guidelines, regulations, notices, and other key items issued in 2025, countdown style.
This column highlights findings from Pathways’ Document Depot, our 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.
Almost 820 medtech policy items from 67 organizations representing more than 100 countries were recorded in Pathways’ Document Depot in 2025. There is no objective answer to what the most significant or important documents are on the list. What new policies matter most depends on a manufacturer’s clinical focus, technology, geography, and multiple other factors.
Still, it’s natural to want to organize, analyze, and categorize information to help make sense of it. And that’s the goal of compiling this 2025 top 10 list, to reflect regulations, guidance documents, and other policy items that we believe have a significant impact on the largest proportion of industry, that touch on weighty themes in medtech policymaking, or that simply prompt important conversations about regulation and reimbursement in the sector. To cast a wider net, for each entry, we identified a related document as an honorable mention.
Without further ado:
10. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
US FDA, June 26
Over the past 15 years or so, attention to cybersecurity in medical devices has rapidly evolved from somewhat of a curiosity (and plot device on spy thriller TV) to a fundamental legal requirement faced by every device manufacturer. This major guidance update published over the summer reflects contemporary realities, laying out the statutory rules of the road for ensuring new and marketed devices are secure and emphasizing that it is almost always the case that your product is a “cyber device” for which these requirements must be heeded in submissions and quality documentation. Read carefully and don’t forget your SBOM.
| Honorable mention Computer Software Assurance for Production and Quality System Software US FDA, September 23 This technical guidance was long awaited by many in industry. It has fundamental relevance to the operations of just about every company, at least those planning to market in the US, as it details the approach manufacturers must use to validate the software they rely on for production of their devices and/or to manage their quality system. It reflects the transition from the old-school “computer system validation” method to the modern, risk-based “assurance” framework that FDA has now adopted. |
