지침,참고문헌 | MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

MDCG 2019-11_guidance_qualification_classification_software.pdf (273.9K) [32]

1. Scope and purpose of this document
This document, which primarily targets medical software manufacturers, defines the criteria for the
qualification of software falling within the scope of the new medical devices regulations1 and provides
guidance on the application of classification criteria for software under Regulation (EU) 2017/745 –
MDR and Regulation (EU) 2017/746 – IVDR.2 The guidance also provides information related to
placing on the market. The classification criteria (classification rules) are set out in Annex VIII of the
Medical Devices Regulation (EU) 2017/745 (MDR) and Annex VIII of the In vitro Diagnostic
Medical Devices Regulation (EU) 2017/746 (IVDR).
The criteria specified in this document shall also apply to applications (commonly referred to as apps),
may they be operating on a mobile phone, in the cloud or on other platforms.
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