Italy | Customized medical devices, clarifications from the Medical Device Coordination Group (MDCG)


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In March 2021, the Medical Device Coordination Group (MDCG) published the MDCG 2021-3 document containing a series of questions and answers on bespoke devices and considerations on adapted medical devices and patient-matched medical devices. ).

This is a European-wide document aimed at addressing the most relevant issues related to bespoke devices that fall under Regulation (EU) 2017/745 on medical devices (MDR).

CONTINUE READING ON: salute.gov.it

                   

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