Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology
Por:
Fraser, AG, Byrne, RA, Kautzner, J, Butchart, EG, Szymanski, P, Leggeri, I, de Boer, RA, Caiani, EG, Van de Werf, F, Vardas, PE, Badimon, L
Publicada:
14 jul 2020
Resumen:
The new European Union (EU) law governing the regulatory approval of medical devices that entered into force in May 2017 will now take effect from 26 May 2021. Here, we consider how it will change daily practice for cardiologists, cardiac surgeons, and healthcare professionals. Clinical evidence for any high-risk device must be reported by the manufacturer in a Summary of Safety and Clinical Performance (SSCP) that will be publicly available in the European Union Database on Medical Devices (Eudamed) maintained by the European Commission; this will facilitate evidence-based choices of which devices to recommend. Hospitals must record all device implantations, and each high-risk device will be trackable by Unique Device Identification (UDI). Important new roles are envisaged for clinicians, scientists, and engineers in EU Expert Panels-in particular to scrutinize clinical data submitted by manufacturers for certain high-risk devices and the evaluations of that data made by notified bodies. They will advise manufacturers on the design of their clinical studies and recommend to regulators when new technical specifications or guidance are needed. Physicians should support post-market surveillance by reporting adverse events and by contributing to comprehensive medical device registries. A second law on In Vitro Diagnostic Medical Devices will take effect from 2022. We encourage all healthcare professionals to contribute proactively to these new systems, in order to enhance the efficacy and safety of high-risk devices and to promote equitable access to effective innovations. The European Society of Cardiology will continue to advise EU regulators on appropriate clinical evaluation of high-risk devices.
Filiaciones:
Fraser, AG:
Cardiff Univ, Sch Med, Cardiff CF14 4XN, Wales
Katholieke Univ Leuven, Dept Cardiovasc Sci, Herestr 49, B-3000 Leuven, Belgium
Byrne, RA:
Dublin Cardiovasc Res Inst, Mater Private Hosp, Dublin D07 WKW8, Ireland
Royal Coll Surgeons Ireland, Sch Pharm & Biomol Sci, Dublin D02 VN51, Ireland
Kautzner, J:
Inst Clin & Expt Med, Videnska 1958-59, Prague 14021 4, Czech Republic
Butchart, EG:
Univ Hosp Wales, Cardiff CF14 4XW, Wales
Szymanski, P:
MSWiA Cent Clin Hosp, Ctr Postgrad Med Educ, Ul Woloska 137, PL-02507 Warsaw, Poland
Leggeri, I:
European Soc Cardiol, Advocacy Div, European Heart House,2035 Route Colles Les Templi, F-06903 Sophia Antipolis, France
de Boer, RA:
Univ Med Ctr Groningen, Dept Cardiol, Hanzepl 1, NL-9713 GZ Groningen, Netherlands
Caiani, EG:
Politecn Milan, Dept Elect Informat & Bioengn, Piazza L da Vinci 32, I-20133 Milan, Italy
Van de Werf, F:
Katholieke Univ Leuven, Dept Cardiovasc Sci, Herestr 49, B-3000 Leuven, Belgium
Vardas, PE:
Hygeia Hosp Grp, Heart Sect, 4 Erythrou Stavrou Str & Kifisias, GR-15123 Athens, Greece
Badimon, L:
IR Hosp Santa Creu i St Pau, Convent ICCC, Cardiovasc Program, C St Antoni Maria Claret 167, Barcelona 08025, Spain
IR Hosp Santa Creu i St Pau, Convent ICCC, CiberCV, C St Antoni Maria Claret 167, Barcelona 08025, Spain
Bronze
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