Section 7 - Solutions to Essential Requirements Instructions Manufacturer’s Please indicate how relevant Essential Requirements (Annex I) of the Directive are met NSAI Review Ensure that the solutions to the Essential Requirements are completed and reference the location of the supporting documentation. Reference should also be made to the Harmonised Standards used. Reviewer & date: Queries? No Yes Number(s) Section 8 -Compliance with Harmonised Standards Instructions Manufacturer’s Please list the relevant Harmonised Standards and identify where compliance is demonstrated: If standards other than Harmonised Standards are used or where Harmonised Standards are not available, please rationalise their use. For IVDD, see Note - The 3 standards below are shown as indication only- please include all other relevant Harmonised Standards from the applicable website(s) above. Table 3 Sample Applicable Harmonised Standards List – – Harmonised Standard Compliant YES/NO – EN ISO 13485:2003 YES EN ISO 14971: 2007 YES EN 980:2008 YES Table 3 Applicable Harmonised Standards List – Harmonised Standard Compliant YES/NO –
Section 7 - Solutions to Essential Requirements Manufacturer’s Instructions Please indicate how relevant Essential Requirements (Annex I) of the Directive are met NSAI Review Ensure that the solutions to the Essential Requirements are completed and reference the location of the supporting documentation. Reference should also be made to the Harmonised Standards used. Reviewer & date: Queries? No Yes Number(s) Section 8 -Compliance with Harmonised Standards Manufacturer’s Instructions Please list the relevant Harmonised Standards and identify where compliance is demonstrated: If standards other than Harmonised Standards are used or where Harmonised Standards are not available, please rationalise their use. For IVDD, see Note - The 3 standards below are shown as indication only- please include all other relevant Harmonised Standards from the applicable website(s) above. Table 3 – Sample – Applicable Harmonised Standards List Harmonised Standard Compliant – YES/NO EN ISO 13485:2003 YES EN ISO 14971: 2007 YES EN 980:2008 YES Table 3 – Applicable Harmonised Standards List Harmonised Standard Compliant – YES/NO
GRF-25-26.docx