The Declaration of Conformity is a declaration made by the manufacturer of equipment that equipment is in conformity with the requirements of an EU Directive.
The Declaration of Conformity is issued by the manufacturer to accompany each item they sell.
It declares that they guarantee that each piece of equipment sold is in conformity with the Directive(s) mentioned.
The Declaration of Conformity can cover one directive or several directives.
Each piece of equipment placed on the market must be accompanied by the Declaration of Conformity
covering the relevant directives.
The basic requirements for a Declaration of Conformity are:
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Polmed.de as the Authorized European Representative, can help you in preparing and creating a Declaration of Conformity in accordance with all requirements of the medical directives.