When does stand-alone software qualify as a medical device in the European Union? (under review): The CJEU decision in SNITEM and what it implies for the next generation of medical devices

TY - JOUR

T1 - When does stand-alone software qualify as a medical device in the European Union? (under review)

T2 - The CJEU decision in SNITEM and what it implies for the next generation of medical devices

AU - Minssen, Timo

AU - Mimler, Marc

AU - Mak, Vivian

PY - 2019/12/7

Y1 - 2019/12/7

N2 - This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates. It also signifies a paradigm shift with a rapidly increasing digitalization of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical AI and Big Data.

AB - This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates. It also signifies a paradigm shift with a rapidly increasing digitalization of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical AI and Big Data.

KW - Faculty of Law

KW - Software

KW - Medical Device Regulation

KW - Medical Device Directive

KW - Medical devices

KW - Healthcare

KW - E-health

KW - digital health

KW - Algorithms

KW - Apps

M3 - Journal article

SN - 0967-0742

JO - Medical Law Review

JF - Medical Law Review

ER -