Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception
Journal
Expert review of medical devices
Date Issued
April 1, 2024
Author(s)
DOI
10.1080/17434440.2024.2334931
Abstract
Regulation has a key role for medical devices throughout their lifecycle aiming to guarantee effectiveness and safety for users. Requirements of Regulation (EU) 2017/745 (MDR) have an impact on novel and previously approved systems. Identification of key stakeholders' needs can support effective implementation of MDR improving the translation to clinical practice of vascular ageing assessment. The aim of this work is to explore knowledge and perception of medical device regulatory framework in vascular ageing field.