[Regulatory requirements for software medical devices: Comparison between Europe, the United States, and Algeria]

Abstract

Software Medical Device (SWMD) are essential digital tools used in the healthcare sector for various medical applications. Like any medical device, MDS are subject to strict and rigorous regulations that vary from country to country, aiming to ensure their quality, safety, and effectiveness. This study examines the regulation of SWMD and compares the definitions, classifications, and approval processes in Algeria, Europe, and the United States, pointing out the similarities and differences among these regions. Regulatory documents were collected and analysed to provide an overview of the approaches adopted by each system. In Europe, Regulation (EU) 2017/745 (MDR) sets strict standards for the safety and effectiveness of medical devices, including software, with enhanced requirements for risk management, clinical evaluation, and post-market surveillance. In the United States, the FDA is the main regulatory body, with specific procedures for the classification, evaluation, and approval of devices. In Algeria, the regulatory framework for medical devices, including software, requires enhancement compared to these systems. This involves establishing regulatory requirements and guidelines that align with internationally recognized standards, such as ISO 13485, ISO 14971, and IEC 62304, which is specific to medical device software.

Keywords: Algerian regulation; European regulation; FDA; Logiciels dispositifs médicaux; Medical device software; Réglementation algérienne; Réglementation européenne.