How to write an EU Declaration of Conformity?
What is an EU Declaration of Conformity?
An EU Declaration of Conformity (DoC) is a legal document in which the manufacturer states that their device complies with the applicable European regulations (MDR or IVDR).
It must be signed by a legally authorised person and must accompany the product on the EU market.
What must an EU Declaration of Conformity include?
1. Manufacturer and/or Authorised Representative information
Include the full name and business address of the manufacturer.
If an EU Authorised Representative is involved, their details must be listed as well.
2. Product identification
Clearly state the model, type, or serial number of the device.
If relevant, you can also include an image to help ensure traceability.
3. Intended purpose and traceability
Briefly describe the intended use of the device and ensure the product is fully traceable through the documentation.
4. Applicable legislation and harmonised standards
Specify whether the device complies with Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR).
List all harmonised standards and, if applicable, common specifications used to demonstrate compliance, with full title and version number.
5. Involvement of a Notified Body (if applicable)
If a Notified Body was involved in the conformity assessment process, you must include:
- The name and identification number of the body
- The type of conformity assessment performed
- The certificate number
This is essential for Class Is, Im, Ir devices or any other case where third-party assessment is required.
6. Statement of responsibility and signature
Add a clear statement that the manufacturer takes full responsibility for compliance.
The DoC must be signed by an authorised person, with their name, position, date, and place of issue.
What happens if your DoC is incomplete or incorrect?
A non-compliant Declaration of Conformity can block CE marking, delay market access, and expose your company to regulatory penalties or product withdrawals.
This is not a document you can afford to overlook.
Does the Authorised Representative need to be included?
Yes, if your company is based outside the EU and you’ve appointed an AR, their name and address must be included in the declaration.
They share legal responsibilities with you and must appear clearly in your documentation.
Need help drafting or reviewing your DoC?
We assist medical device and IVD manufacturers, as well as Authorised Representatives, in preparing fully compliant EU Declarations of Conformity.
Whether you’re starting from scratch or just need a final check: We’re here to support you.
For official EU guidance on Declarations of Conformity, you can also visit this link.
