Comparative table GSPR – Essential Requirements (v4)

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This table provides a line-by-line comparison between the General Safety and Performance Requirements of Annex I of Regulation (EU) 2017/745 (MDR) and the Essential Requirements of Annex I of Directive 93/42/EEC (MDD). It allows you to transfer the information from the essential requirements checklists that you have at your disposal, and to complete them in order to constitute a technical documentation in compliance with the MDR.

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This table, available in Word, is designed to help you update your technical documentation in accordance with Directive 93/42/EEC in order to bring it into line with Regulation (EU) 2017/745. It allows you to identify which requirements are identical between the MDD and the MDR, which ones are different, and which ones are completely new. It is designed so that it can be incorporated, after completion, into your technical documentation according to the MDR.