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 · Eur Urol · 2023

expert_opinion · Level V

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Abstract

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.

Medical subject headings