EU CE marking · technical-file retention
How long must you keep your technical file?
After the last product is placed on the market, you must keep the technical documentation and the EU Declaration of Conformity for a fixed number of years. Pick your product regime and role to get the period — and the keep-until date.
The rule, in one line
Under the EU New Legislative Framework, manufacturers must keep the technical documentation and the EU Declaration of Conformity for 10 years after the product is placed on the market (e.g. Low Voltage Directive 2014/35/EU, PPE Regulation (EU) 2016/425). Importers keep a copy of the Declaration and ensure the technical documentation is available for the same 10 years. For medical devices the period is at least 10 years after the last device is placed on the market — and at least 15 years for implantable devices (MDR Art 10(8)).
Official sources: Low Voltage Directive 2014/35/EU · PPE Regulation 2016/425 · MDR 2017/745
Retention period
10 years
…after the last product covered by the Declaration of Conformity is placed on the EU market.
What you must keep
As the manufacturer: the full technical documentation and the EU Declaration of Conformity (plus any certificates), available for the competent authorities.
Per-product memo
Retention memo (PDF) · €29
A print-ready pack for one product: the retention period, the keep-until date, what to keep for your role, the legal basis, and source links — for your compliance file.
This is guidance, not legal advice. The export restates the retention rule for your inputs; it does not cover every sector instrument's specific period.
What this tool is — and isn't
This checker gives the technical-documentation retention period for the regime and role you pick, using EUR-Lex (LVD 2014/35/EU, PPE 2016/425, MDR 2017/745). It is an estimate and orientation, not legal advice, and it does not cover every sector instrument's specific period, document-content requirements, or national record-keeping rules. Verify against the linked official sources.
How the determination works
1. The product regime
Most CE-marked products carry a 10-year retention period (the New Legislative Framework standard). Medical devices use at least 10 years — and 15 for implantable devices.
2. The start point
The clock starts when the last product covered by the Declaration of Conformity is placed on the EU market. Enter that date to get your keep-until date.
3. Manufacturer vs importer
Manufacturers keep the full technical documentation and the Declaration; importers keep a copy of the Declaration and ensure the documentation is available — for the same period.
Frequently asked questions
- How long do I keep the technical file?
- Ten years after the product is placed on the market for most CE-marked products; at least 10 years for medical devices and at least 15 years for implantable medical devices.
- When does the clock start?
- From the day the last product covered by the EU Declaration of Conformity is placed on the EU market — not from manufacture and not from sale to the end user.
- Do importers have the same duty?
- Importers keep a copy of the EU Declaration of Conformity and ensure the technical documentation can be made available to authorities on request — for the same period as the manufacturer.
- Why 15 years for implants?
- The Medical Devices Regulation (Art 10(8)) sets a longer 15-year retention for implantable devices, given their longer in-body lifetime and traceability needs.
- Does this period vary by directive?
- The 10-year period is the reference-provision standard across the New Legislative Framework instruments. A few sector regimes set their own; check the specific instrument for edge cases.
- Is this legal advice?
- No. This tool gives the retention period for your regime and role. It is orientation, not legal advice, and does not cover every sector instrument. Verify against the linked official sources.