Abstract
The use of digital health applications in healthcare has gained significant traction in the last couple of decades. This trend has not gone unnoticed by the European regulators and has resulted in the adoption of two new regulations: the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. The former will have a significant impact on the use and development of mHealth applications. Changes in the classification system, conformity assessment procedures and the use of the unique device identification system will affect developers of mHealth applications in particular. Additionally, due to the expansion of the contents of and access to the European Medical Device Database (EUDAMED), healthcare providers and patients will have greater transparency regarding medical devices. This chapter describes these changes and analyses their effect on the development and use of mHealth applications. It also analyses the interplay between the Medical Device Regulation, the In Vitro Diagnostic Medical Device Regulation and the General Data Protection Regulation.
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