Medical Device Regulations for custom-made devices: answers to ten important questions

نویسندگان

چکیده

The 1990s saw the introduction of three European directives that aimed to harmonise medical device legislation within Union (EU) and these were given effect in United Kingdom (UK) by Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). Dental professionals EU who manufactured custom-made devices required do so accordance with relevant requirements one directives, Council Directive 93/42/EEC (Medical Device [MDD]). MDD has been replaced Regulation 2017/745 [EU MDR]) this paper answers some important questions regarding ways which affects provision a dental setting.

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ژورنال

عنوان ژورنال: BDJ team

سال: 2022

ISSN: ['2054-7617']

DOI: https://doi.org/10.1038/s41407-022-0802-5