Checklists - MDD
Checklist for EC Declaration of Conformity (Annex VII)
Before CE-marking his medical devices, the manufacturer must prepare an EC Declaration of Conformity ensuring and declaring that the products in question meet the applicable provisions of Directive 93/42/EEC. The declaration of conformity is prepared on the basis of the technical documentation.
By using this checklist the manufacturer makes sure that the technical documentation contains all relevant requirements.
Size: 33 KB.Checklist for EC Design-Examination (Annex II, §4)
By using this checklist the manufacturer makes sure that his product meets the requirements dealt with in Annex II, Section 4 concerning EC design-examination.
Size: 28 KB.
Checklist for EC Type-Examination (Annex III)
This checklist draws up all the requirements of Annex III of Directive 93/42/EEC concerning EC type-examination. By using this checklist when preparing the documentation according to Annex III you make sure that all relevant requirements have been addressed.
Size: 35 KB.
Checklist - Essential Requirements
By using this checklist you make sure that all relevant requirements according to Annex I of Directive 93/42/EEC have been addressed.
Size: 139 KB.
Checklist - Quality System Assessment
With this checklist you can verify that your quality system meets all the requirements of the EN ISO 13485, ISO 9000, Directive 93/42/EEC concerning medical devices and 21CFR, Part 820 (1996) (United States Food and Drug Administration Quality System Regulation).
Size: 991 KB.
Checklist for Statement concerning Devices for Special Purposes (Annex VIII)
If the manufacturer produces medical devices for special purposes according to Annex VIII of Directive 93/42/EEC, he is obliged to draw up a statement containing the information stipulated in Section 2 of Annex VIII. In order to help you draw up this statement, DGM has prepared this checklist.
Size: 33 KB.
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