Development and Evaluation of a Framework for Assessing Reprocessing Suitability of Single-Use Medical Devices under the EU MDR

Sammanfattning

Single-use medical devices (SUDs) are increasingly used in healthcare but contribute to increased waste generation, costs, and dependence on external supply chains. Reprocessing has been proposed as a strategy to mitigate these challenges; however, implementation under the EU Medical Device Regulation (MDR) remains challenging due to complex requirements and limited guidance on how regulatory requirements should be operationalized in practice. To help address one aspect of this challenge, a framework for assessing reprocessing suitability of SUDs under the EU MDR was developed and evaluated. The work involved translating regulatory requirements into practical assessment methods through consideration of device design, materials, functionality, risk management, and reprocessing processes. The framework was developed through analysis of regulations, standards and scientific literature. The results indicate that assessment of reprocessing suitability requires integration of both technical and regulatory considerations to ensure maintenance of device safety and performance. The proposed framework provides a structured approach for supporting such assessments and may contribute to more consistent implementation of reprocessing practices under the MDR.