Hardian Health, Haywards Heath, UK.
Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Br J Hosp Med (Lond). 2021 Feb 2;82(2):1-5. doi: 10.12968/hmed.2021.0074. Epub 2021 Feb 22.
With the exit of the UK from the European Union and the European Union Regulation 201/745 coming into effect on 26 May 2021, the regulatory landscape for medical devices is undergoing a substantial change, the implications of which will be felt by those procuring and using medical devices in clinical settings. This article outlines the changes that clinicians, as users of medical devices, should be aware of in the immediate future.
随着英国脱欧和欧盟法规 201/745 于 2021 年 5 月 26 日生效，医疗器械的监管格局正在发生重大变化，这将对在临床环境中采购和使用医疗器械的人产生影响。本文概述了医疗器械使用者（即临床医生）在不久的将来应该注意的变化。
