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The Declaration of Conformity

 

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:

  • Identify the directive(s) with which conformity is claimed.
  • Identify the manufacturer of the equipment
  • Identify European Authorized representative of the manufacturer.
  • Identify any EN harmonized standards used.
  • Signed and dated by a person with enough responsibility to ensure that the Declaration is true, for example a Director or Chief Engineer.
Polmed-18

important notice

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.

 

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