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Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation 1 Introduction Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirements for sampling of Class IIa / Class IIb and Class B / Class C devices for the assessment of the technical documentation. Article 52(4) and (6) of the MDR and Article 48(7) and (9) of the IVDR establish the need to assess the technical documentation of at least one representative device per generic device group (for Class IIb and Class C) and for each category of devices (for Class IIa and Class B) prior to issuing the certificate. Section 2.3 and 3.4 of Annex IX of both Regulations (and section 10 of Annex XI of the MDR) defines that the quality management system assessment has to be accompanied by the assessment of technical documentation for devices selected on a representative basis. Section 4.5.2(a) of Annex VII of both Regulations1 requires the notified body to draw up and keep up to date, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III prior to the audit. Section 4.5.2(b) of Annex VII requires the notified body to assess the technical documentation as preparation for the audit(s). This assessment is expected to be finalised in due time of such audit(s). [생략]

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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. [생략]