A Commentary on Decentralized Privacy-Preserving Proximity Tracing in the Context of the EU Legal Framework for Medical Devices (Working Paper)

Abstract

So far, the debate on contact tracing technologies to fight COVID19 heavily focused on the ethical and legal aspects concerning privacy and data protection. This Commentary (working paper) analyses the applicability of the EU Medical Devices Directive to the software for decentralized privacy-preserving proximity tracing by following MEDDEV 2.1/6 guidelines’ five-step approach. It concludes that the software at stake might qualify as a medical device.