Technical File retention requirements per EU directive

The Technical File and the Declaration of Conformity must be retained beyond the active product life. Each EU directive specifies the retention period in its own article — most converge on ten years from the last unit placed on the EU market, with the Medical Device Regulation extending for implantable devices.

This article lists the retention period under each major CE marking directive in 2026, cites the specific article that sets it, explains when the retention clock starts, and covers who holds the retention obligation when the manufacturer is non-EU.

Retention periods by directive

Most directives converge on ten years from the last unit placed on the market.

When the retention clock starts

The phrase "last unit placed on the market" is operative. A "unit placed on the market" is defined in Article 3(1) of Regulation (EU) 2019/1020:

"'placing on the market' means the first making available of a product on the Union market"

For an industrial sensor manufacturer that ships continuous production to EU distributors between 2026 and 2032, the last-placed date is the date in 2032 when the final unit left the manufacturer's EU-bound supply chain. The retention clock starts on that date — the Technical File must be available until 2042 (CRA, RED, LVD, EMC) or 2047 (MDR implantable).

For software products distributed online, each download is a placing on the market. The last-placed date is the date the download was last made available — typically the date the product or its support is discontinued.

Discontinuing the product does not reset the clock. If a manufacturer discontinues a product family in 2030 but had already last placed a unit in 2028, the retention period runs until 2038, not 2040.

Who holds the retention obligation

The manufacturer

Always. The retention obligation rests with the manufacturer of record — the legal entity that signed the Declaration of Conformity. This obligation does not transfer with product sale or with brand change.

The EU Authorised Representative (EC REP)

For non-EU manufacturers, the EC REP holds a parallel retention obligation for the same period:

• CRA Article 13(2)(a):

  "keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities for the period referred to in Article 13(11)"

• RED Article 11(2)(a) — parallel obligation
• MDR Article 11(3)(a) — parallel obligation

The EC REP's copy must be kept current as the manufacturer updates the master. See EU Authorised Representative guide.

The Importer (for some directives)

Under Regulation 2019/1020 Article 4(3)(b), the EU-established importer of certain products has parallel retention duties for the DoC for 10 years. The Technical File obligation does not always extend to the Importer but verification of its existence does.

Successors

If the manufacturer is acquired, the acquirer inherits the retention obligation. If the manufacturer dissolves without succession, the obligation cannot be enforced against a non-existent entity — but products already on the market remain subject to member-state liability and recall regimes.

Format and accessibility

The Technical File may be electronic or paper under Regulation 2019/1020 Article 18. The operative requirement: the manufacturer (or EC REP, where applicable) must produce the file promptly when requested by a market surveillance authority, in the language the authority specifies, within a reasonable deadline.

Acceptable storage approaches:

• Version-controlled repositories — Git, document management systems
• Cloud document storage — Confluence, SharePoint, Google Drive
• Specialist compliance platforms — including Cenitia

Long-term accessibility is the manufacturer's responsibility. Storing the Technical File in a proprietary format that requires a specific vendor's software to read carries the risk that the vendor disappears mid-retention. PDF/A, plain Markdown, IEC 82079-compliant formats, and other open formats are durable choices.

When the retention period matters

Three scenarios where retention compliance is actively tested:

1. Market surveillance investigation — an authority requests the Technical File during an inspection. The manufacturer (or EC REP) must produce it within the deadline specified.
2. Notified Body audit during certificate renewal — the NB requests historic Technical File versions to verify ongoing conformity.
3. Litigation following a product safety incident — product liability proceedings can reach back to the date the unit was placed on the market, requiring the Technical File version that was in force at that date.

The retention period gives authorities and Notified Bodies the legal window to demand documentation. Missing the file during that window constitutes presumption of non-conformity under Regulation 2019/1020 Article 14(4).

How Cenitia handles retention

Cenitia retains every Technical File version, every DoC version, and every supporting document (SBOM, test report, risk assessment) for the ten-year retention period required by CRA Annex VII and longer for MDR-relevant products. Hosting persists across product lifecycle changes and manufacturer organisational changes — including in the event the manufacturer ceases to subscribe to Cenitia (a final-export option ensures the manufacturer can take their archive elsewhere).

For non-EU manufacturers using Inovasense as their EC REP, the EC REP retention obligation is satisfied automatically through the synchronised document portal.

Frequently asked questions

How long must the Technical File be retained under most EU directives?

Ten years from the date the last unit of the product was placed on the EU market for the majority of CE marking directives — the Cyber Resilience Act, Radio Equipment Directive, Low Voltage Directive, EMC Directive, Machinery Regulation, and General Product Safety Regulation. The Medical Device Regulation extends retention to ten years for most devices and fifteen years for implantable devices. Manufacturer retention applies to both the Technical File and the Declaration of Conformity.

When does the retention clock start?

On the date the last unit of the product family was placed on the EU market — that is, the last unit was supplied for distribution, consumption, or use in the EU market in the course of a commercial activity. Discontinuing the product does not reset the clock. The manufacturer's record of the last-placed date determines the clock start; in practice this is the last ship date from the manufacturer's EU-bound supply chain.

Does the EC REP also need to retain the Technical File?

Yes, under CRA Article 13(2)(a), RED Article 11(2)(a), MDR Article 11(3)(a) and parallel provisions. The EC REP holds a copy of the Declaration of Conformity and the Technical File at the disposal of market surveillance authorities for the same retention period as the manufacturer. The EC REP's copy must be kept current as the manufacturer updates the master.

What happens if the manufacturer ceases to exist before the retention period ends?

Under most directives, the obligation transfers to a successor entity. If the manufacturer is acquired, the acquirer typically inherits the retention obligation. If the manufacturer is dissolved without succession, member-state market surveillance authorities lose their ability to demand the documentation — but products already placed on the market remain subject to recall and withdrawal under member-state liability regimes. In practice, manufacturers preparing to dissolve transfer Technical Files to a custodian (sometimes the EC REP) for the remainder of the retention period.

Can I retain the Technical File electronically only?

Yes under Article 18 of Regulation (EU) 2019/1020. The format requirement is that the file be produced promptly when requested by a market surveillance authority in the language the authority specifies. Cloud storage, version-controlled repositories, and document management systems all qualify. The manufacturer must ensure long-term accessibility — including beyond the lifetime of any specific software vendor used to store it.

What evidence does the manufacturer need to prove the retention clock starts when claimed?

Records of the last unit placed on the EU market — typically the manufacturer's shipping records, ERP system records, or distribution agreement records that document the last EU-bound shipment of the product family. Member-state market surveillance authorities can challenge the claimed last-placed date if they have evidence of later sales; the manufacturer's burden is to maintain accurate records.

Related from the Library

• Technical File 101 — pillar context
• Technical File for IoT devices template — concrete IoT structure
• Declaration of Conformity 101 — parallel DoC retention
• EU Authorised Representative guide — EC REP parallel retention obligation

Further reading

• Cyber Resilience Act Article 13(11) and Annex VII
• Radio Equipment Directive Article 11(7)
• MDR Article 10(8) — retention periods for medical devices
• Regulation 2019/1020 Article 18 — technical documentation availability
• Regulation 2019/1020 Article 4 — importer and EC REP obligations

Last reviewed: 30 June 2026. Cited regulations watched continuously by Cenitia — when one amends, this article is flagged for update.