Development of a tool to assess knowledge and perceptions of the regulatory framework applied to medical devices for vascular ageing evaluation

Background: Regulation is part of the technology innovation process and has a key role within the lifecycle of a medical device aiming at ensuring efectiveness and safety for users (1). Ever-increasing regulatory requirements (e.g., the Regulation MDR (EU) 2017/745) impact on the development of novel and already approved systems (2, 3). Debating and raising awareness is important since it can improve the transfer of knowledge and expertise among the relevant stakeholders. Thus, the implementation of a survey to explore knowledge and perception of the regulatory framework of medical devices for the assessment of vascular age can be helpful for the involved community.

Methods: A multidisciplinary team including clinicians, researchers and developers from VascAgeNet was established to design and implement a digital questionnaire. A secure, open-source, two-factor authentication system for generation, distribution, and data collection of the survey supported by the European Commission (EUSurvey, https://ec.europa.eu/eusurvey) was adopted.

Results: The questionnaire has received ethical clearance by National Council of Research, Italy (Notifcation 0063984/2021) and University College London (17999/002) Research Ethics Committees and is being distributed digitally (e.g., within VascAgeNet, Artery Society etc.). The anonymous questionnaire is available at https://ec.europa.eu/eusur vey/runner/REGULATORYSurvey2022 or by scanning the QR code below, it takes approximately 10 min to complete.

Conclusions: A survey related to regulation and medical devices for vascular ageing assessment has been developed and is available for the community. The results could inspire concrete actions reducing gap between research and clinical practice.
The survey was developed by the COST Action CA18216, VascAgeNet
supported by COST (www.cost.eu).