Get CE MARK TECHNICAL FILE

The letters ' CE ' appear on many products that are traded on the single market in the European Economic Area ( EEA ). The CE marking is required for many products. It: shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements.

Certifying Your Product with CE Marking The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety.

The Difference Between a Technical File and a Design Dossier Technical files, sometimes referred to as technical documentation, are required for all Class I, Class IIa and Class IIb medical devices. Design dossiers refer to the technical documentation for Class III devices.

The technical file represents a set of documents that demonstrate the conformity of a product with the CE-marking legislation. The documentation must specify the applicable product safety requirements and cover the design, manufacture, and operation of the product.

User instructions, markings, labels, information. Basically every technical file must contain a copy of the user instructions, the markings on the product and packaging and any other relevant information for the user.

CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

Technical File Information Description of the apparatus, usually accompanied by a block diagram. Wiring and circuit diagrams. General Arrangement drawing. List of standards applied. Records of risk assessments and assessments to standards. Description of control philosophy/logic. Datasheets for critical sub-assemblies.

Essentially your file must contain the following elements. Device description & specifications. Information to be supplied by the manufacturer. Design & manufacturing information. General safety & performance requirements. Verification & validation information. Risk assessment. Declaration of Conformity.