All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives for CE-marked products.
EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do not usually have access to the technical file.
A technical file for CE marking has mainly two parts.
The first part includes all the necessary administrative information and a summary of the most important technical data to help the reviewer understand the significance of the detailed technical data.
The second section is the specific documents necessary to verify that the manufacturer meets all the claims and performance requirements and controlled the risks.
According to the Directive and the Guide, the technical file must include:
• Details about the manufacturer and its European Representative (when applicable), such as the name and address;
• The device’s identifying information;
• The device’s class, class rationale, and the directives and standards that apply;
• A general description of the product and its variants;
• Product designs and any explanations to make the designs easy to understand;
• A risk management file;
• Any inspection results and design calculations;
• Pre-clinical evaluation including evidence that the device complies with the standards and meets the claimed performance;
• The clinical evaluation, including the analyzed clinical data
• The manufacturing process, equivalent to the Device Master Record as defined in the US QSR);
• Any sterilization methods used, including demonstrating controlling the product’s sterility where applicable;
• The solutions the manufacturer adopts so the device conforms to essential requirements listed in Annex I of the applicable Directive; and
• The device’s labeling (label on product and packaging, and instructions for use).