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In the heterogenous category of digital healthcare technologies, software with a medical purpose - i.e. therapy, diagnosis, prevention of a disease or monitoring of adherence to treatment - is expected have a strong impact. Indeed, it conforms to models of development and market access which are typical of information technology and unusual for healthcare. Avoiding any regulatory uncertainty is crucial for companies and competent authorities. In the European Union (EU), software with a medical purpose qualifies as a medical device, for which a strong regulatory framework is already in place. However, for patient-managed digital medical devices (pDMDs), i.e. software with a medical purpose intended to be used directly by patients, some open issues are still on the ground. These issues arise both at the EU level, related to risk-based classification and clinical evaluation, and the national level, related to prescription and reimbursement policies. The aim of this article is to analyse the classification and regulation of pDMDs in the EU, exploring the need of additional definitions, legislation or guidance. |
