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The Impact of the Medical Devices Regulation on the Pharmaceutical Industry: A Focus on Combination Products and Digital Health Technologies

Vladimir Murovec, Annabelle Bruyndonckx, Sander Vogt


This piece addresses the impact of Regulation (EU) 2017/745 on medical devices (MDR) on the pharmaceutical industry. The article approaches this from two different angles, both of which demonstrate the rising importance of new medical devices legislation across developing trends in the pharmaceutical industry. The first section concerns the MDR’s challenges for combination products. Before discussing the applicable legal frameworks, this paper starts by outlining an approach to defining and categorising combinations products. The implications of the MDR on the safety and performance requirements of certain combination products are further examined to clarify the expansions of the MDR’s scope of application. The second section of this paper focuses on the MDR’s approach to digital health technologies. The different ways in which software products are covered by the MDR is discussed, together with the consequences of rearranging such products in higher risk classes. Furthermore, the flexible notion of ‘economic operator’ is contemplated in terms of a pharmaceutical company’s activities in digital health. The reinforced obligations imposed on economic operators and a range of other legal issues in the lifecycle of digital health technologies that will be affected by the MDR are also considered.

Vladimir Murovec, Supervising Associate at Simmons & Simmons. For Correspondence: <>. Annabelle Bruyndonckx, Counsel at Simmons & Simmons. For Correspondence: <>. Sander Vogt is an LL.M. Candidate at the University of Pennsylvania Law School (Fellow of the Belgian American Educational Foundation, Dean's Scholar).


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