EU Declaration of Conformity
A legally binding document in which a medical device manufacturer declares that their product meets all applicable requirements of EU MDR 2017/745. The Declaration of Conformity must accompany every CE-marked medical device.
The EU Declaration of Conformity (DoC) is a formal statement by the manufacturer that a medical device complies with all applicable provisions of the EU Medical Device Regulation (MDR 2017/745). It is a mandatory document for every CE-marked medical device and must be kept up to date throughout the device's market life.
Required contents
Under EU MDR Article 19 and Annex IV, the Declaration of Conformity must include: product and UDI-DI identification, manufacturer name and address, a statement that the declaration is issued under the sole responsibility of the manufacturer, reference to the regulation (EU 2017/745), the device risk class and conformity assessment procedure used, Notified Body details (where applicable), and a reference to relevant harmonized standards and Common Specifications applied.
Role in tender compliance
The Declaration of Conformity is one of the most commonly requested documents in EU medical device tenders. Procurement teams check that it references MDR (not the legacy MDD), lists the correct Notified Body, is signed and dated, and covers the specific device model being offered. An outdated or incorrect DoC is a frequent cause of tender disqualification.