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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. A survey was developed within VascAgeNet and distributed in the community by means of the EUSurvey platform. Results were derived from 94 participants (27% clinicians, 62% researchers, 11% companies) and evidenced mostly a fair knowledge of MDR (despite self-judged as poor by 51%). Safety (83%), validation (56%), risk management (50%) were considered relevant and associated with the regulatory process. Structured support and regulatory procedures connected with medical devices in daily practice at the institutional level are lacking (only 33% report availability of a regulatory department). Regulation was recognized relevant by the VascAgeNet community and specific support and training in medical device regulatory science was considered important. A direct link with the regulatory sector is not yet easily available. [ABSTRACT FROM AUTHOR]

Background: Regulation is part of the technology innovation process and has a key role within the lifecycle of a medical device aiming at ensuring effectiveness 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/eusur vey) was adopted. Results: The questionnaire has received ethical clearance by National Council of Research, Italy (Notification 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/REGUL ATORY Surve y2022 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. [ABSTRACT FROM AUTHOR]

The development and use of medical devices are subject to regulations and approval activities to enter the market. These are mandatory for manufacturers and have important implications for all involved professionals. In fact, the innovation process, starting from a clinical need, includes the identification of a solution and its implementation, and requires taking into account crucial aspects according to regulatory requirements in each phase. These include exemplary validation or risk management. The aim of this work is to provide an overview of some key aspects of regulation and their implementation in medical devices for vascular ageing assessment. In particular, regulatory scenarios in Europe, Australia and the United States of America are described and examples of marketed medical devices for vascular ageing assessment are provided. Strong and active links among industry, research, clinical experts and governments adds value for the community, requiring the ability to communicate between different skills and backgrounds: this multidisciplinary and multi-partner collaboration can speed up the innovation process and can increase the system's efficiency related to both social and ethical impact. [ABSTRACT FROM AUTHOR]