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WebDevices shall be designed and manufactured in such a way that they are suitable for the purposes referred to in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the performance they are intended to achieve, taking account of the generally acknowledged state of the art. Webaccount the generally acknowledged state of the art. The GSPRs are identified in Annex I of the EU IVDR. Like GSPR 1, the majority of the requirements are principle- based, ensuring that, as state of the art changes, a manufacturer considers if the IVD remains in compliance. The GSPRs are divided into three major groups: pa schools prerequisites
Is Your Medical Device ‘State of the Art?’ - Quality Digest
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