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



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Antich-Isern, Pau and Caro-Barri, Julia and Aparicio Blanco, Juan (2021) The combination of medical devices and medicinal products revisited from the new European legal framework. International journal of pharmaceutics, 607 . p. 120992. ISSN 0378-5173

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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 26th 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.

Item Type:Article
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CRUE-CSIC (Acuerdos Transformativos 2021)

Uncontrolled Keywords:Borderline product; Drug-device combination; Integral; Co-packaged; CE marking; Regulation (EU) No 2017/745; Combination product
Subjects:Medical sciences > Pharmacy > Drugs
Social sciences > Law > Legislation
Social sciences > Law > European Union
ID Code:70417
Deposited On:14 Feb 2022 10:27
Last Modified:21 Feb 2022 15:04

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