CE Technical Documentation: Complete Guide to Your Technical File

The Technical Documentation file (also called the Technical File or TC File) is the backbone of CE compliance. If market surveillance authorities request it and you can’t produce it within 48 hours, your product is considered non-compliant. I’ve reviewed hundreds of Technical Files, and the most common problem isn’t missing documents — it’s disorganization. Here’s exactly what you need and how to structure it. For a complete overview of the CE certification process, see my CE certification guide.

What Documents Are Required in a CE Technical File?

A complete Technical File includes: product description (name, model, intended use), design and manufacturing drawings, list of applicable directives and harmonized standards, risk assessment report, test reports (from accredited labs), the Declaration of Conformity, EU-type examination certificate (if applicable), and a copy of the CE marking artwork. Some directives require additional documents — check your directive’s Annex III requirements.

How to Structure Your Technical File

I recommend this folder structure: Section 1 — Product Description. Section 2 — Design & Manufacturing. Section 3 — Applicable Directives & Standards. Section 4 — Risk Assessment. Section 5 — Test Reports. Section 6 — Declaration of Conformity. Section 7 — Notified Body Certificates (if applicable). Section 8 — CE Marking Artwork. Version each document with date and revision number. Store it in a secure digital repository with regular backups. My CE certification cost guide covers what you should budget for documentation preparation.

How Long Must You Keep the Technical File?

10 years after the last product was manufactured. For medical devices under MDR, it’s extended to 15 years. If your company ceases operations, the Technical File must be transferred to a designated authorized representative or competent authority. This is a common compliance gap — companies stop maintaining documentation after the initial certification, then face penalties when a product is audited years later.

Common Technical Documentation Mistakes

Missing risk assessment (required even for simple products), outdated harmonized standards, test reports from unaccredited labs, incomplete product descriptions (vague “electronic device” without specifications), and failure to update files when standards change. These are the top 5 findings in market surveillance audits. Regular documentation reviews (every 12 months) prevent these issues.

Do You Need a Consultant for the Technical File?

For simple products with self-declaration (Module A), most manufacturers can prepare the file internally using templates. For complex products with Notified Body involvement, a certification consultant ($100-200/hour) is a worthwhile investment. The consultant ensures your documentation meets the standards before submission, saving you from expensive rejection cycles. See my guide to finding the right consultant.

References

1. European Commission: CE Marking for Manufacturers — Official guidance on Technical File requirements.
2. ISO 17050-1: Declaration of Conformity — Standard format for supplier’s declaration of conformity.

Digital documentation management is becoming standard practice. Using a cloud-based technical file repository with version control ensures you always have the latest documents ready for market surveillance inspections. Some certification management platforms offer automated standards tracking that alerts you when harmonized standards are updated. These tools cost 0-200/month but eliminate the most common compliance gap — missed standard updates.