The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices

Autor: Green, James IJ
Zdroj: British Journal of Hospital Medicine; December 2020, Vol. 81 Issue: 12 p1-6, 6p
Abstrakt: The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.
Databáze: Supplemental Index