The Evidence-Governance Deficit: How Fragmented Ownership Weakens Conformity Assessment under the EU Medical Devices Regulation
Conformity assessment under the EU Medical Devices Regulation relies on technical documentation produced across fragmented private organisations. Drawing on the Commission’s 14th notified-body survey, 98,378 FDA 510(k) records and 24 expert interviews, this article identifies an evidence-governance deficit. Among 50...