Certification Pathways for Open-Source Medical Devices

Abstract

Open-source medical devices (OSMDs) have the potential to reshape medical industry and to rethink our approach to healthcare, advancing towards universal health coverage by means of a more equitable access to technologies for good health and well-being. Pioneering examples have demonstrated that open-source medical devices can reach patients in remote, low- and middle-income settings, through innovative approaches to supply chain management. In some cases, production in the point-of-care is enabled, working directly from cloud-shared blueprints. However, more often than not, first experiences with open-source medical technologies have progressed without an adequate consideration of the regulatory landscape and without analysing certification pathways, which can place patients at risk and hinder the emergence of open-source medical devices as reliable and sustainable alternatives. The bright future of open-source technologies, especially in connection with healthcare, relies on their being designed for compliance with relevant legislations and in accordance with internationally accepted standards. Even if the harmonization of medical devices regulations worldwide is still far from completion, the European Union Medical Device Regulation 745/2017 is already emerging as inspiring model for many low- and middle-income settings. In consequence, this chapter provides a detailed description of the key aspects of the EU MDR 745/2017 and particularizes it to the case of OSMDs. Classification rules and certification pathways are presented, and special cases, including personalized medical devices and software as medical device, are discussed. Finally, a comparative study with other relevant medical regulations, which may also affect OSMDs, is presented.