The Evidence-Governance Deficit: How Fragmented Ownership Weakens Conformity Assessment under the EU Medical Devices Regulation

Abstract 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 MDR-designated bodies, 35 report that at most half of submissions are complete at first assessment; respondents estimate that 58% of certification time lies with manufacturers. Five channels weaken the assessment chain: sign-off latency, documentation inconsistency, audit-trail fragmentation, update-obligation diffusion and a data-protection layer that compounds the other four. Modules containing personal health data engage Article 9 GDPR; relevant electronic health data will also face the EHDS’s phased secondary-use regime, principally from 2029. The Commission’s December 2025 simplification proposal addresses documentation content, procedures and responsibilities for outsourced design and manufacture, but leaves wider coordination incompletely specified. Comparing legislative amendment, common specifications, harmonised standards and MDCG guidance, the article proposes risk-based evidence-governance schedules and harmonised completeness categories. Common specifications could address technical requirements within Article 9(1) MDR; any new autonomous manufacturer duty would require legislative amendment.