3 OK Annex VII, Functional product descriptions, explanatory section 3, 3rd - descriptions necessary to understand the above mentioned drawing and diagrams and the operation of the product 4 OK Annex VII, Conformance to the essential requirements of Annex I section 3, 4th - (including list of harmonized standards applied, specifying whether used in full or in part), including solutions adopted when not applying the harmonized standards in full 5 OK Annex VII, The results of the risk analysis (risk management file). section 3, 4th - 6 OK Annex VII, For sterile products, descriptions of the methods used section 3, 5th - and the validation report. 7 OK Annex VII, Results of the design calculations and inspection section 3, 6th - activities. 8 OK Annex VII, Technical test results (electrical safety test, mechanical section 3, 6th - safety test, EMC test (emission & immunity), etc.). 9 Annex VII, Furthermore a description verifying that the essential section 3, 6th - requirements are adhered to when connecting devices which are specified by the manufacturer. 10 Annex VII, The risk control option analysis (e.g. as per EN ISO section 3, 7th - 14971:2007, section 6.2) 11 Annex VII, Pre-clinical evaluation section 3, 8th - 12 Annex VII, Clinical evaluation in accordance with Annex X section 3, 9th - concerning "Clinical Evaluation" (and MEDDEV 2.7.1.) 13 Annex VII, Labeling (marking on the device, marking on the section 3, 10th - packaging and the CE-marking itself).
3 Annex VII, section 3, 3rd - Functional product descriptions, explanatory descriptions necessary to understand the above mentioned drawing and diagrams and the operation of the product OK 4 Annex VII, section 3, 4th - Conformance to the essential requirements of Annex I (including list of harmonized standards applied, specifying whether used in full or in part), including solutions adopted when not applying the harmonized standards in full OK 5 Annex VII, section 3, 4th - The results of the risk analysis (risk management file). OK 6 Annex VII, section 3, 5th - For sterile products, descriptions of the methods used and the validation report. OK 7 Annex VII, section 3, 6th - Results of the design calculations and inspection activities. OK 8 Annex VII, section 3, 6th - Technical test results (electrical safety test, mechanical safety test, EMC test (emission & immunity), etc.). OK 9 Annex VII, section 3, 6th - Furthermore a description verifying that the essential requirements are adhered to when connecting devices which are specified by the manufacturer. 10 Annex VII, section 3, 7th - The risk control option analysis (e.g. as per EN ISO 14971:2007, section 6.2) 11 Annex VII, section 3, 8th - Pre-clinical evaluation 12 Annex VII, section 3, 9th - Clinical evaluation in accordance with Annex X concerning "Clinical Evaluation" (and MEDDEV 2.7.1.) 13 Annex VII, section 3, 10th - Labeling (marking on the device, marking on the packaging and the CE-marking itself).
bl_10.1-004e_checklist_for_ec_decl._of_conf._v8.0_0.docx