The combination of medical devices and medicinal products revisited from the new European legal framework

Abstract

Medical devices and medicinal products have many similarities in their nature, scope or specific medical purposes, and despite the differences in their principal means of action, they are often used in combination. Indeed, many medicinal products depend on medical devices for their administration, and it is increasingly common for medical devices to contain medicinal substances to support their action. Therefore, the combination of medicinal products and medical devices provides additional benefits for patients. However, their higher technical complexity requires a strengthening of their authorisation and certification requirements. In this regard, more comprehensive requirements and classification rules are introduced by a new European regulation on medical devices that fully applies from May 26^th 2021. On account of their therapeutic significance, this review aims at gaining insight into the borderline between medical devices and medicinal products in this new 2021 regulatory framework. For the first time, any item containing a medical device and a medicinal product will have both parts evaluated. Through exemplification of both marketed and investigational devices incorporating medicinal substances and drug-device combinations, the new European requirements and their implications are thoroughly illustrated herein.

Keywords: Borderline product; CE marking; Co-packaged; Combination product; Drug-device combination; Integral; Regulation (EU) No 2017/745.