Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception

ABSTRACT

Background

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.

Research design and methods

A survey was developed within VascAgeNet and distributed in the community by means of the EUSurvey platform.

Results

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).

Conclusions

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.

KEYWORDS:

• Medical device
• regulation
• vascular ageing
• MDR
• survey

Article highlights

• Regulation has a key role for medical devices throughout their lifecycle to guarantee effectiveness and safety.

• A survey was developed within VascAgeNet to explore knowledge and perception of medical device regulation (with a focus on MDR (UE) 2017/745) in the vascular ageing field.

• A fair knowledge of MDR was found but structured support and regulatory procedures at the institutional level are lacking.

• The regulatory framework was recognized relevant by the VascAgeNet community.

• Support and training in medical device regulatory science was considered important.

List of abbreviation

MDR = (EU) 2017/745 Medical Device Regulation

Declaration of interest

Elisabetta Bianchini is co-founder of QUIPU s.r.l., Pisa, Italy a spin-off company of the Italian National Research Council and the University of Pisa developing software medical devices. Marisa Testa is the founder and CEO of Thema s.r.l., Imola (BO), Italy, a consultancy company specialized in Quality and Regulatory Affairs for medical and in-vitro medical devices. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Ethics approval and consent to participate

This survey has been reviewed and approved by the CNR Ethics Committee (Notification 0063984/2021) and the Research Ethics Committee UCL (Notification of Ethics Approval Project ID: 17999/002). Consent to participate was required at the beginning of the questionnaire.

Availability of data and materials

The dataset analyzed during the current study is available from the corresponding author on reasonable request.

Authors’ contributions

EB and MRM, designed the study, implemented the survey and the data analysis. All authors participated in the design and development of the survey. CP was responsible for dissemination of the survey. AGP and AT supported data analysis. RMB, REC, DTP, CCM, MT reviewed literature and critically reviewed the manuscript. All authors read and approved the final manuscript.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17434440.2024.2334931.

Additional information

Funding

This paper is based upon work from the COST Action CA18216 “Network for Research in Vascular Ageing” supported by COST (European Cooperation in Science and Technology; https://www.cost.eu).