Medical device research update after the adoption of the EU legislation (MDR)
Year: 2025
Type: article
Abstract: ABSTRACT Despite the 2017 update to European medical device regulation and its entry into force in 2021, many doubts persist about its real-world application in medical device (MD) research in Spain. The development of MDs requires collaboration among numerous stakeholders, including researchers, ethics committees, notified bodies, the Spanish Agency of Medicines and Medical Devices, manufacturers, and other involved parties—all of whom have had to adapt to the new regulatory framework. This has required a significant effort and consumption of resources to understand and apply the different clinical practice guidelines to unify protocols in MD research and ensure the safety and efficacy profile of these products. Although challenges remain, the adoption of this legislation has fostered collaboration among stakeholders, enabling progress and a better understanding of the new obstacles it presents. The aim of this review is to define, in a practical way, the content of this regulation and expose the perspectives of the different actors involved in the development of MD.
Authors: Jon Zubiaur, José Ramón Rumoroso Cuevas, M. Concepción Rodríguez Mateos, Gloria Hernández, Iciar Alfonso Farnós, María Aláez, Sara Pich, Jordi Martorell, Emilio Paredes, Alejandro Escario, Pedro P. Fernández Rivero, Eduardo Jiménez-Carles, and, Armando Pérez de Prado
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4414623897
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