The Declaration of conformity (DoC) is one of the key documents within technical documentation. Technical documentation is necessary for manufacturers as this is a detailed record that provides essential information on the design, manufacture, and operation.
EU Declaration of Conformity is signed by the manufacturer to declare that the products comply with the EU requirements. By signing it, the manufacturer takes full responsibility for the product’s compliance with the applicable EU law.
What should an EU MDR DoC contain.
A typical DoC should contain the following details:
- Name and Address of the manufacturer or that of the appointed Authorized Representative.
- Product’s serial number, part number, model, or type identification.
- Statement declaring full responsibility of the device/product.
- Identification of product allowing traceability (This can include an image).
- Details of the notified body (if applicable).
- Legislation by means of which the product complies, along with any harmonized standards and or the means used to prove compliance.
- Name of device manufacturer and signature.
- Declaration issue date along with the expiry date mentioned.
- Additional / supplementary information (if applicable).
Steps involved in writing a Declaration of conformity.
Before drawing up a DoC for a medical device, it is imperative to understand what device class it belongs to. Medical devices are classified according to Annex VIII of the EU Medical Device Regulations (EU MDR). These are the steps that need to be followed once the classification of the device is done.
Identify the EU requirements for the product
Check if the requirements are met
Check if the product needs to be tested by any of the Notified Bodies
Test the product. Prepare the technical file
Keep documents available for at least ten years.
What language should it be in?
The Declaration of Conformity should be in one of the languages accepted within the EU. Since DoC is an important document, it must be comprehensible to the reader. Hence, it should be ideally written in the language of the country where the product is marketed or sold.
Is DoC and CE certificate the same?
No, the two documents are different. DoC is a declaration that is signed by the manufacturer stating that the medical device conforms to the EU requirements. Whereas CE certificate is issued after a conformity assessment is carried out either by the manufacturer themselves or by a notified body (also known as conformity assessment organization).