EU Declaration of Conformity

What is an EU Declaration of Conformity?

The EU Declaration of Conformity is the manufacturer’s formal statement that the medical device covered by the declaration meets the applicable requirements of the EU Medical Device Regulation and any other relevant Union legislation. Article 19 and Annex IV of the MDR establish its requirements.

By drawing up the declaration, the manufacturer assumes responsibility for the device’s compliance. It is therefore an output of completed conformity assessment, not a substitute for the technical evidence supporting conformity.

What information must the declaration contain?

Annex IV requires information that clearly identifies the manufacturer and device. This includes the manufacturer’s name and address, the Basic UDI-DI, product identification, intended purpose where needed for identification, risk class and a statement of conformity.

The declaration also identifies applicable Union legislation and common specifications, and includes notified body and certificate information where applicable. It must state the place and date of issue and identify the person signing on behalf of the manufacturer. If several EU laws require a declaration, one declaration can cover all relevant Union acts.

Who signs the EU Declaration of Conformity?

An authorized person signs for and on behalf of the manufacturer. A notified body does not issue or sign the manufacturer’s declaration. Where notified body involvement is required, the declaration references the body, conformity assessment procedure and relevant certificates.

A non-EU manufacturer remains responsible for the declaration even though it appoints an EU authorized representative. The representative’s details are included where applicable. See our EU Authorized Representative guide for the distinction between these roles.

When must the declaration be updated?

Article 19 requires the manufacturer to keep the declaration continuously updated. Changes to the device, manufacturer, Basic UDI-DI, applicable legislation, conformity assessment or certificates can require review and revision. Translation requirements also depend on the Member States where the device is made available.

The declaration should remain consistent with the current technical documentation, certificates and labeling. Conflicting identifiers or outdated certificate information can undermine traceability and conformity claims.

How does the declaration relate to CE marking?

For devices other than custom-made or investigational devices, the manufacturer draws up the declaration after demonstrating conformity through the applicable procedure and before affixing the CE mark. Our EU MDR CE marking guide explains the broader process, while the EU MDR consulting overview covers technical documentation and conformity planning.