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- James Ij Green.
- Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.
- Brit J Hosp Med. 2020 Dec 2; 81 (12): 1-6.
AbstractThe 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.
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