Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union

Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union

The regulation of clinical trials for medicinal products and medical devices has undergone numerous changes in recent years in the European Union, challenging manufacturers and national regulatory agencies as well. With the introduction of combined drug–device products, the regulatory landscape has...

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Bibliographic Details
Main Authors: Ádám Pannonhalmi, Bence Sipos, Róbert Imre Kurucz, Gábor Katona, Lajos Kemény, Ildikó Csóka
Format: Article
Language:English
Published: MDPI AG 2025-06-01
Series:Pharmaceuticals
Subjects:
medical device
medicinal product
drug development
clinical trial
regulatory science
medical device regulation
Online Access:https://www.mdpi.com/1424-8247/18/6/876
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