Sarcouncil Journal of Multidisciplinary

Abstract: The regulatory environment of medical devices in the European Union has been altered by regulation (EU) 2017/745 (MDR), and the regulation added more requirements in terms of technical documentation, lifecycle traceability, and post-market surveillance. This review is based on Design History Files (DHFs) remediation of legacy device portfolios that is part of MDR, what strategies and best practices may be applied to make sure that documentation and risk-management systems and clinical evidence systems are harmonized. A literature review was conducted in a systematic manner; thematic analysis was conducted and a conceptual remediation framework proposed. Among the discoveries that are of the most significant interest, one should mention the application of gap-analysis, risk-based prioritization, the improvement of traceability, and constant monitoring of remediation results. The research opportunities in the future include standardization of digital tools in the remediation of DHF, integration of real-world evidence (RWE) into the documentation process, and worldwide unification of regulation. The review comes to a conclusion that regulatory preparedness and access to the market according to MDR presupposes the availability of DHF remediation and provides a systematic framework that can guide manufacturers and regulatory experts.