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The Future of Medical Devices in Europe Is at Stake: Concerns over the Implementation of the Medical Devices Regulation 2017/745.
Albisinni, Simone; Rassweiler, Jens; van Poppel, Hendrik.
Afiliação
  • Albisinni S; Urology Unit, Department of Surgical Sciences, Tor Vergata University Hospital, University of Rome Tor Vergata, Rome, Italy. Electronic address: simone.albisinni@uniroma2.it.
  • Rassweiler J; Danube Private University (DPU), Krems-Stein, Austria.
  • van Poppel H; Urology, KU Leuven, Leuven, Belgium; EAU Policy Office, Arnhem, The Netherlands.
Eur Urol ; 83(3): 191-192, 2023 03.
Article em En | MEDLINE | ID: mdl-36609009
In May 2024, all medical devices in Europe will require to comply with the new Medical Device Regulation 2017/745, including those we have been using for years. Currently, there are major delays and problems associated with this new certification. As clinicians, we express our serious concerns regarding whether the system will be ready on time to ensure that all the medical devices that we use will be available for patient care.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Legislação de Dispositivos Médicos Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Legislação de Dispositivos Médicos Idioma: En Ano de publicação: 2023 Tipo de documento: Article