A Transfer Route Without a Stop Route: Safety Execution Under the Proposed Article 5(5) Amendments to the MDR and IVDR

Abstract

COM (2025) 1023 would permit specified transfers of in-house devices between health institutions, coupled with bilateral traceability and recipient-to-transferor incident reporting, yet it does not state how a safety finding becomes a release-specific instruction, reaches every deployment, produces local cessation of use and returns as verified closure. This article examines that missing execution link. Union safety law mandates identification and then treats it as a proxy for actionability, although traceability and a use-stop ask different questions and need different record units; the argument is developed against ordinary recall rules and tested on software, assay, printed-device, emergency and onward-transfer cases. A two-institution record should connect controlled release identity, local acceptance and deployment, change history, incident escalation, scoped use-stop, execution acknowledgement, remediation and custody closure. The operative communication and acknowledgement duties belong in Article 5(5) itself, with modality-dependent fields left to guidance. So designed, the exemption keeps its exceptional character without treating the market-route recall framework as directly applicable.