DECLARATION OF CONFORMITIES
The European Union Declaration of Conformity (DoC) in which a Bio/Data Corporation formally declares the compliance of a product with the essential health, safety and environmental requirements of the relevant directives.
It reflects Bio/Data Corporation's commitment to quality and its overall compliance with 93/42/EEC, the European medical device directive. The Document of Conformity is signed by the head of quality or regulatory affairs.
Bio/Data Corporation declares the products meet the provision of the Council of Directive 98/79/EC for In Vitro Diagnostic Medical Devices and Directive 98/79/EC as transposed in the national laws of Member States
The Declaration of Conformity is valid for ten years from the date of placing the product on the market unless the relevant CE directives provide for any other duration.