지침,참고문헌 | MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

MDCG 2020-4 nb_audits_covid-19_en.pdf (357.5K) [44]

1. Introduction
In the context of the current COVID-19 global outbreak as well as the rapid spread of the virus across various regions of the globe, the resulting travel and quarantine restrictions have significantly affected the ability of notified bodies to conduct mandatory on-site audits under the medical devices legislation. Therefore, in the interest of public health, this document has been developed to outline temporary extraordinary measures for notified bodies to follow in this interim period in order to allow continued availability of safe medical devices to the market and assist in the prevention of the risk of medical device shortages. In this context, it is considered that alternative solutions to carrying out on-site audits by notified bodies under the medical devices Directives1 should be allowed under specific circumstances, including the possibility to perform remote audits under certain conditions.
This guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation.
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