ARTICLE SUMMARY:
UK government health agencies published two important documents captured in Pathways’ Document Depot last month seeking substantial upgrades to regulatory and market access pathways for medtech. The items will be significant for firms entering the UK market and could also be influential globally.
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.
The UK government has been rethinking every stop along its medtech market access pathway in recent years as part of broader initiatives to establish post-Brexit frameworks and improve its global economic standing. This work has led to a growing list of consultations, guidance documents, white papers, pilot programs, and, soon, the official adoption of a UK-focused medical device/IVD regulatory framework.
UK agencies issued two notable policy documents in May stemming from these efforts (see box, “Docs of the Month: May”). Both hold significant long-term implications for accessing the UK market and could also be relevant in advancing global medtech policymaking.
