EU IVDR Declaration of Conformity: Annex IV Content, Basic UDI-DI and Retention

1. Key takeaways

The EU Declaration of Conformity (EU DoC) is a statement of compliance that the manufacturer issues in its own name. Under Article 17, the manufacturer draws up the DoC after demonstrating conformity with the applicable conformity assessment procedure, having fulfilled the obligations of Article 10(5); the minimum content is set out in Annex IV. The DoC must be continuously updated and translated into the official language or languages of the Member State in which the device is made available, as determined by that Member State. The Basic UDI-DI must appear on the DoC under Article 24(6).

Because the DoC is the document that links a specific device, identified by its Basic UDI-DI, to the legal declarations of the manufacturer, errors in it propagate into every downstream touchpoint: tenders, customs checks, EUDAMED data fields and the paperwork of distributors and importers. Keeping the DoC accurate is therefore not a clerical task but a controlled regulatory activity, with defined triggers, owners and a retention duty of at least 10 years under Article 10(7).

2. Legal basis

3. Expert insights

Insight 1: The DoC is a declaration, not a certificate, and its issuer is always the manufacturer.

The obligation under Article 17 and Article 10(5) rests on the manufacturer. What a notified body issues is a conformity certificate under Article 51; the DoC is drawn up by the manufacturer itself, and this holds even for Class D devices. Confusing the two documents leads to concrete errors: companies list the notified body as the issuer, cite certificate numbers where the regulation requires the declaration, or fill EUDAMED data fields with certificate identifiers instead of the Basic UDI-DI. The distinction matters legally, because the DoC is the manufacturer attesting conformity with the requirements of the Regulation, while the certificate is the notified body attesting the outcome of its assessment. Both documents exist side by side, and neither replaces the other.

Insight 2: The Basic UDI-DI is the key anchor between the DoC and EUDAMED.

Article 24(6) requires the Basic UDI-DI of the device to appear on the DoC. Article 28(3) requires the manufacturer to use the single registration number (SRN) when applying for conformity assessment to a notified body. Article 29(2)(a) requires the summary of safety and performance to contain the Basic UDI-DI and, where issued, the SRN. Together these provisions form a complete data chain running from the SRN, through the Basic UDI-DI, down to the device-level UDI-DI. The DoC sits at the middle of that chain: it identifies the device through the Basic UDI-DI and links it to the certificates and to the registration records. When the Basic UDI-DI on the DoC does not match the EUDAMED record, tenders and customs procedures stall, so this identifier should be verified field by field at every reissue.

Insight 3: The DoC must be kept current as the product and the regulatory basis change.

Annex IV requires the DoC to state, among other items, the device identification, the name and address of the manufacturer, the provisions under which the declaration is made, the applicable conformity assessment procedure and, where applicable, the name and the four-digit number of the notified body. Each of these fields has its own change triggers: additional variants added to the product family, a change of intended purpose, a change of notified body, or an update in the versions of the standards relied upon. Any of these events obliges the manufacturer to revise and re-sign the DoC. Under Article 10(7), the DoC must be kept together with the technical documentation and a copy of the certificates for at least 10 years, which means the historical versions also need orderly archiving, not only the current one.

Insight 4: For Class A non-sterile devices, the DoC is the only gateway document.

Under Article 48(10), conformity assessment of Class A non-sterile devices is completed by the manufacturer issuing the EU DoC, with no notified body involved. For this category the DoC is therefore not a supporting formality but the substantive compliance document: it is the visible legal evidence that the manufacturer has performed the assessment, met the general safety and performance requirements and drawn up the technical documentation. Errors in such a DoC cannot be backstopped by a notified body certificate, because none exists. This makes the review of the DoC for Class A non-sterile products a control point worth the same rigour as a technical file review.

4. Practical recommendations

1. Build a DoC template mapped item by item against the minimum content list of Annex IV, and annotate each field with its data source, such as the Basic UDI-DI register, the SRN and the certificate numbers, so that every reissue can be verified mechanically.
2. Bring the DoC under change control: whenever a trigger occurs, update and re-sign within a defined deadline. As a practical estimate, aim for updating within 30 days, and record the deadline in the procedure.
3. For products placed on the market in several Member States, manage the language versions under Article 10(10), translating and archiving the DoC in step with the information supplied with the device.
4. Maintain a consistency checklist between the DoC fields and the device data records in EUDAMED, checking the Basic UDI-DI, the manufacturer data and, where applicable, the notified body details at every update.
5. Set the retention and retrieval mechanism for the DoC under Article 10(7), covering the 10-year period together with the technical documentation and certificate copies, and define who can produce the archived versions on request.

5. Verification checklist

• □ The DoC lists all items of the minimum content required by Annex IV
• □ The Basic UDI-DI appears on the DoC under Article 24(6)
• □ The name and four-digit number of the notified body, where applicable, are correctly stated
• □ The DoC is under change control with defined triggers and update deadlines (deadlines as a practical estimate)
• □ Language versions are managed under Article 10(10)
• □ The DoC, technical documentation and certificate copies are retained for at least 10 years under Article 10(7)

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with Declaration of Conformity services under the IVDR: Annex IV content mapping, Basic UDI-DI and SRN data-chain verification, change-trigger procedures, multilingual DoC management and EUDAMED consistency checks. Contact us at info@grzanglobal.com for a DoC compliance review.

Legal information verified as of 29 October 2026.