ARTICLE SUMMARY:
The EU Medical Device Regulation doesn’t contain any special provisions for devices addressing rare diseases or subpopulations, but policymakers worked with what they have last month in a guidance document laying out an approach to allow reduced clinical requirements for orphan devices. Here’s a look at the plan and some comparisons to US humanitarian device exemptions.
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.
Guidance documents are principally a mechanism for government bodies to explain how existing policies will be implemented and enforced. But in some cases, regulatory agencies can stretch the functions of guidance, using them as a means to more broadly interpret existing authorities to establish new policies that aren’t explicitly spelled out in law, regulation, or other decree.
The EU applied the latter approach in penning a significant guidance document last month. The guidance from the European Medical Device Coordination Group describes a special pathway for orphan medical devices where notified bodies can accept less premarket clinical data than the Medical Device Regulation would typically allow.
