TY - JOUR
T1 - Medical device regulation in vascular ageing assessment
T2 - a VascAgeNet survey exploring knowledge and perception
AU - Martina, Maria Raffaella
AU - Park, Chloe
AU - Alastruey, Jordi
AU - Bruno, Rosa Maria
AU - Climie, Rachel
AU - Dogan, Soner
AU - Tuna, Bilge Guvenc
AU - Jerončić, Ana
AU - Manouchehri, Marjan
AU - Panayiotou, Andrie G
AU - Tamarri, Silvia
AU - Terentes-Printzios, Dimitrios
AU - Testa, Marisa
AU - Triantafyllou, Areti
AU - Mayer, Christopher C
AU - Bianchini, Elisabetta
PY - 2024/4/2
Y1 - 2024/4/2
N2 - 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.
AB - 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.
KW - Medical device
KW - regulation
KW - vascular ageing
KW - MDR
KW - Survey
UR - https://doi.org/10.1080/17434440.2024.2334931
U2 - 10.1080/17434440.2024.2334931
DO - 10.1080/17434440.2024.2334931
M3 - Article
C2 - 38557297
SN - 1743-4440
VL - 21
SP - 335
EP - 347
JO - Expert Review of Medical Devices
JF - Expert Review of Medical Devices
IS - 4
ER -