EU Declaration of Conformity under MDR Article 19 and Annex IV

The EU Declaration of Conformity is the manufacturer’s own instrument of self-declaration under the EU MDR. This article explains what MDR Article 19 and Annex IV require, how the Basic UDI-DI ties the declaration into EUDAMED, and which actors are mistakenly treated as able to rely on another party’s declaration.

1. Key takeaways

Under MDR Article 19, manufacturers must draw up the EU Declaration of Conformity (EU DoC) for each device and keep it up to date, declaring that the device conforms to the requirements of the MDR. Annex IV defines the information the declaration must contain, including the name and address of the manufacturer, the Basic UDI-DI, the device name and intended purpose, the risk class, the conformity assessment procedure followed, and the name and number of the notified body where applicable.

The declaration is drawn up and updated by the manufacturer, not issued by the notified body, which issues certificates. The retention period runs in step with the technical documentation: under Article 10(8), at least 10 years, and for implantable devices at least 15 years, counted from the day the last device is placed on the market. Entities that become manufacturers under Article 16, such as relabellers and repackagers, must issue their own declaration and cannot rely on the original manufacturer’s document.

The declaration also interacts with the CE marking obligation: the manufacturer may only affix the CE marking where the conformity assessment procedure has been completed and the declaration has been drawn up. Keeping the declaration, the certificate and the marking decisions inside one controlled workflow prevents the situation where marked units are on the market while the underlying declaration is outdated or inconsistent with the certificate in force.

2. Legal basis

The table below lists the provisions cited in this article.

Read together, these provisions define who declares, what the declaration must contain, how long it must be kept, and which economic operators step into the manufacturer role and therefore into the declaration duty.

For entities issuing their own declaration under Article 16, the practical starting point is to review which Article 10 obligations transfer with the manufacturer role, including the information obligations, the technical documentation duty and the post-market surveillance duties, and to confirm that their own Basic UDI-DI structure covers the devices placed on the market under their name before the first declaration is signed.

3. Expert insights

Insight one: the EU DoC is the manufacturer’s self-declaration document, not a document issued by the notified body.

Article 19 places the duty to draw up and update the declaration on the manufacturer. What the notified body issues is a certificate, not a declaration. The two documents exist side by side in the device file: the certificate proves that third-party assessment has been passed, while the declaration proves that the manufacturer has completed its own attestation and accepted responsibility for conformity. Confusing the two leads to files where the declaration is missing altogether or wrongly attributed to the notified body.

Insight two: the entry of the Basic UDI-DI into the declaration is a new MDR element.

Annex IV requires the declaration to contain the Basic UDI-DI. This binds the declaration, the EUDAMED database records, the technical documentation and the certificates to the same primary key, so that regulators can trace the whole evidence chain through a single identifier. A Basic UDI-DI in the declaration that does not match the database is a direct market surveillance finding, which makes reconciliation between the declaration and EUDAMED a routine pre-release task rather than a one-time setup.

Insight three: the declaration must be kept up to date, and its retention period matches the documentation retention period.

Under Article 10(8), the EU Declaration of Conformity must be kept together with the technical documentation for at least 10 years, and for implantable devices at least 15 years, counted from the day the last device is placed on the market. When the device changes, when a certificate is renewed, or when the Basic UDI-DI is adjusted, the declaration must be updated in step and the superseded version archived, so the file shows both the current and the historical state.

Insight four: entities that become manufacturers under Article 16 must issue their own declaration.

Importers or distributors that are deemed manufacturers under Article 16, for example by placing devices on the market under their own name or trademark, relabelling or repackaging, must issue their own EU Declaration of Conformity and assume the obligations of Article 10. Such entities frequently assume that the original manufacturer’s declaration can simply be reused; that assumption constitutes a substantive violation, because the declaration attests conformity under the declaring manufacturer’s own name and responsibility.

4. Practical recommendations

1. Build the declaration template directly on Annex IV, with mandatory-field validation on each item so nothing can be omitted when a new version is issued.
2. Reconcile the Basic UDI-DI, the device name and the intended purpose in the declaration word for word against the EUDAMED records before release.
3. Run version management for the declaration: changes trigger an update, and old versions are archived and retained in the device file.
4. Configure the retention period for 10 years and 15 years, recording the start point as the day the last device is placed on the market.
5. Ensure entities falling under Article 16 issue their own declaration rather than reusing the original manufacturer’s document.

5. Verification checklist

• □ The declaration has been prepared item by item against Annex IV with no omissions
• □ The Basic UDI-DI matches the EUDAMED record
• □ The notified body name and number are included (where applicable)
• □ A version management mechanism for the declaration has been established
• □ Retention is configured for the 10-year / 15-year tracks
• □ Entities falling under Article 16 have issued their own declarations

Regulatory information verified as of 2026-10-29.

GRZAN supports medical device manufacturers entering and maintaining the EU market under Regulation (EU) 2017/745. Our team drafts and maintains EU Declarations of Conformity against MDR Article 19 and Annex IV, reconciles them with EUDAMED records, and advises Article 16 entities on their own declaration duties. For technical file and conformity support for the EU MDR market, contact info@grzanglobal.com.