Writing a Declaration of Conformity (DoC) 

21 Jan 2025

Writing a Declaration of Conformity (DoC) is one of the most important requirement for medical device manufacturers when entering the European market under the Medical Device Regulation (MDR). A medical device manufacturer cannot sign it before ensuring that all their technical documentation is ready (which itself is a very important document), as the DoC confirms the device complies with all applicable European regulations.

But what exactly is the DoC?  

The Declaration of Conformity or DoC is a legal document written by the medical device manufacturer(s). The content of the DoC is described in Annex IV of MDR 2017/745, but there is no specific format to write it down.  

What does DoC Signify? 

The DoC highlights that a CE-marked product/medical device complies with the applicable legislation. By drafting the EU DoC, the manufacturer assumes the responsibility for compliances with the MDR and all the other Union legislation applicable to the device.  

Which Rules Apply to the DoC? 

The rules applicable to the DoC are mentioned in Article 19 of MDR 2017/745. This means that, in order to prepare their DoC, manufacturers must comply with:  

Statement 

The EU DoC shall state that the requirements specified in the MDR are fulfilled in relation to the device that is covered.  

Continuous Update 

The DoC must be continuously updated, so an expiry date should be added to it (after which the manufacturer may update it). An alternative to updating may be a procedure showing the scenarios in which a change should require a modification in the DoC. 

Annex IV 

Annex IV contains the minimum requirements to be included in the DoC. We will list these requirements ahead of this blog. 

Language of the DoC 

• The manufacturer shall translate the DoC into an official Union language Or languages required by the Member State(s) in which the device is made available.  

• Compliance with Multiple Legislations 

• If a product requires the DoC for several legislations, the manufacturer shall create a single DoC that contains all the information required for identification of the Union legislation to which the declaration relates. ù 

• Compliance to Delegate Acts 

• Although the minimum requirements of the DoC have been listed in Annex IV, they can be subjected to change, as authorized by Article 115 of EU MDR. 

What are the Minimum Content Requirements of EU MDR? 

As we have mentioned above, Annex IV of EU MDR contains all the minimum requirements of EU MDR. These include: 

1. Name of the Company 

Name, registered trade name, or registered trademark of the legal manufacturer.  

2. Single Registration Number 

Single Registration Number or SRN is provided by an electronic system which is set up by the European Commission. If the manufacturer has an Authorized Representative, then they should add their SRN too.  

3. Contact Details 

The place of the business and contact details of the manufacturer and the Authorized Representative. 

4. Statement 

A statement that the DoC is issued under the sole responsibility of the manufacturer. 

5. Basic UDI-DI 

The manufacturer must request for the Basic UDI-DI for their product, as referred to in Part C of Annex VI.  

6. Product 

The manufacturer must include a series of product-related information, listed below:  

• Type of product; 

• Product trade name; 

• Product code;  

• Catalog number to which it belongs 

• Product intended purpose; 

• Any unambiguous reference allowing the identification and traceability of the device (e.g. a photograph). Except the product or trade name, the information allowing the identification and traceability of the product may be provided by the Basic UDI-DI.  

7. Risk Class 

Risk class of the device according to the rules set in Annex VIII of the MDR.  

8. Compliance 

The manufacturer must include a statement that shows their compliance with the MDR Regulation. If the device complies with the other regulations, a compliance statement referring to those regulations should also be included: 

9. Common Specifications 

Reference to any Common Specification used and in relation to which conformity is declared.  

10.  Notified Body 

The information about the Notified Body will be included if the medical device/product belongs to any of these categories: 

• Class Is 

• Class Im 

• Class Ir 

• Class IIa 

• Class IIb 

• Class III 

The following information must be included: 

• Name of the Notified Body; 

• Identification number; 

• Description regarding the conformity assessment procedure 

• CE certificate number;  

• Additional information.  

11.  Requirements for Signature 

Once the manufacturer reaches the end of the document, they must add crucial information, including:  

• Place and date of issue of the DoC; 

• Name and function of the person who signed the DoC; 

• The sign for the person on whose behalf the DoC was signed (if applicable); 

• Signature. 

It is important for the manufacturer to clarify the validity of its DoC. This can be done in various ways, such as  

• Define the number of years in which the DoC is valid (e.g. This DoC is valid for 1 year);  

• Enter the expiry date of the Doc date (e.g. This Doc is valid until the date reported: 2/11/2026) 

Fulfilling all these requirements to produce an EU MDR-compliant DoC can be quite daunting. Medical device manufacturers who are not familiar with these complexities can easily overlook important details and thus run into regulatory problems. But don’t worry because our TSQ&E experts have you covered! Our consultants are familiar with the EU MDR requirements and can help you draft a solid Declaration of Conformity. To find out more and get a quote, book a consultation session today.