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並前往https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-3_en.pdf

MDCG 2021-3 Questions and Answers on Custom-Made ...

to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR). Further guidance on this subject may be elaborated by the MDCG, ...

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