Technical documentation section 1. Device description and specifications:
Content and structure of the EU declaration of conformity (DoC)
The EU declaration of conformity (DoC) is a legally required document that confirms a medical device's compliance with the medical device regulation (MDR) 2017/745. This document must be kept up to date and be available upon request in the official language(s) of the eu member state(s) where the device is placed on the market.
Purpose and legal basis
The eu declaration of conformity serves as the manufacturer's formal statement that the device complies with the requirements set forth in the MDR. It also applies to other relevant eu legislation when the device is subject to multiple regulatory frameworks. In such cases, a single DoC may be issued, covering all applicable regulations.
By issuing this declaration, the manufacturer assumes full legal responsibility for the device's compliance.
Minimum required content of the EU declaration of conformity
According to annex IV of the MDR, the DoC must include the following elements:
Manufacturer and authorized representative details
- Name, registered trade name or trademark
- Single registration number (SRN) (if issued)
- Address of the registered place of business
- If applicable, details of the authorised representative
Statement of sole responsibility
A declaration that the DoC is issued under the sole responsibility of the manufacturer.
Identification and traceability information
- Basic UDI-DI (unique device identification - device identifier)
- Product name, trade name, product code, or catalogue number
- Any other unambiguous reference ensuring traceability, such as a photograph, if applicable
Device classification
Risk class of the device, determined in accordance with annex VIII of the MDR.
Statement of compliance
A statement confirming that the device conforms to MDR 2017/745 and, where applicable, other eu legislation that requires an eu declaration of conformity.
Common specifications (CS), if applicable
References to any cs used in the conformity assessment.
Notified body involvement (if applicable)
- Name and identification number of the notified body
- Description of the conformity assessment procedure performed
- Certificate reference(s) issued by the notified body
Additional information (if applicable)
Signature and issuance details
- Place and date of issue
- Name and function of the person signing the declaration
- Indication of representation (for and on behalf of whom the person is signing)
- Signature
Regulatory updates and amendments
The European Commission is authorized to update the minimum content requirements of the DoC in response to technical progress. Such amendments are made through delegated acts under article 115 of the MDR.
