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EUDocumentation Guide

# CE Technical File Retention: How Long to Keep Records

Complete guide to CE documentation retention requirements. Learn how long to keep technical files, Declaration of Conformity, and test reports for EU compliance.

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At a glance

Retention periods

3

Documentation items

6

FAQs

5

## Retention periods by directive

### Most directives (EMC, LVD, RED, RoHS)

10 years

After the last unit is placed on the EU market

### Medical Device Regulation (MDR)

15 years

After the last unit is placed on the EU market

### Implantable medical devices

30 years

After the last unit is placed on the EU market

## Documentation to retain

*   Keep the EU Declaration of Conformity
*   Maintain the complete technical file
*   Retain test reports from accredited laboratories
*   Store change control documentation
*   Keep post-market surveillance records
*   Document any product modifications or updates

## Frequently Asked Questions

### Does the 10-year retention start from first sale or last manufacture?

Retention starts from the date the last unit is placed on the EU market, not the first sale date. If you continue manufacturing the product, the retention clock doesn't start until production ends.

### Can I store documentation digitally?

Yes, digital storage is acceptable and common. However, you must ensure documents are accessible, readable, and backed up. The format must remain readable for the entire retention period. Consider long-term format compatibility.

### What if I stop selling a product before 10 years?

You must still retain documentation for 10 years after the last unit is placed on the market, even if you stop sales or manufacturing. The obligation is tied to the last unit placed on the market, not business activity.

### Do I need to keep supplier documentation?

Yes. Supplier declarations, material certificates, and component documentation that support your compliance should be retained as part of the technical file. These are evidence for RoHS compliance and other requirements.

### What happens if I can't produce the technical file when requested?

Failure to produce the technical file when requested by market surveillance authorities is a compliance violation. This can lead to product recalls, market bans, and penalties. Maintain organized, accessible documentation.

**Disclaimer:** This page is an educational resource based on official EU sources. It is not legal or engineering advice. Always verify current directive and standard status in the Official Journal before placing any product on the EU market.

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