CE Technical File: Contents, Retention and Preparation

The technical file is the set of documents that shows why a product conforms to the legislation it falls under. Every CE directive and regulation requires one. It is the manufacturer’s evidence, and it is what market surveillance authorities ask for when they have a question about the product.

For your CE technical file, apply to CE Danışmanı (CE Consultant); we prepare it and manage the whole process for you.

What a technical file contains

The exact content depends on the legislation, the product type and the standards applied, so a generic template does not work. The file is built for the specific product. Typical content:

• General description of the product and its intended use
• Product tree covering all models and variants
• Design and manufacturing drawings, circuit diagrams, parts lists and assembly drawings
• List of the legislation and harmonised standards applied
• Check of the essential requirements, item by item
• Risk analysis
• Test reports and inspection results, with the measuring equipment used
• Certificates and declarations of components and suppliers
• Labels, markings, warnings and the CE marking layout
• Instructions for use and technical manual
• Production flow chart and, where relevant, factory production control documents
• EU Declaration of Conformity
• Notified body certificates and reports, where a notified body is involved

How the file is prepared

1. Collect the company and product information.
2. Identify the applicable legislation and standards and list them.
3. Check the essential requirements.
4. Add the risk management documents.
5. Add drawings, diagrams and the description of the product.
6. Add labels, warnings and instructions for use.
7. Add test reports and the records of the measuring equipment and calibration.
8. Draw up the EU Declaration of Conformity.
9. Prepare the CE label in line with the rules.

How long must it be kept?

Unless the legislation says otherwise, the manufacturer keeps the technical file and the declaration of conformity for at least ten years after the last unit is produced.

When can the authorities ask for it?

• During routine market surveillance, a summary of the technical file can be requested and must be provided within the period given.
• If there are serious doubts about conformity, the authorities can request the full file.
• The file is assessed first for health and safety, then for the other public interests covered by the legislation.

Failing to provide the file in time increases the suspicion that the requirements have not been met, and puts the product’s position on the market at risk.

Legislation that requires a technical file

Among others: Machinery, Low Voltage, EMC, RoHS, Pressure Equipment, Simple Pressure Vessels, Personal Protective Equipment, Toys, Lifts, Medical Devices, Gas Appliances, Construction Products, Noise Emission, Ecodesign, Energy Labelling, ATEX and Cosmetics.

Why a template is not enough

A technical file is not a collection of papers. It has to explain why the product is considered compliant, in a way that can be defended when a customer or an authority asks. A file that cannot answer that question also reduces the value of the tests that were paid for.