The CE Mark and the EU Declaration of Conformity: The Final Steps to Place a Medical Device on the European Market

The CE mark and the EU Declaration of Conformity (DoC) are two inseparable elements that mark the final and most critical step for a medical device to be legally placed on the European Union market. The CE mark is the visible declaration of compliance, while the DoC is the legal document through which the manufacturer assumes full responsibility. Correctly implementing these requirements is critical, as any errors can lead to delays in market access.

This article will analyze the core requirements for both of these elements under the MDR, helping your business complete the process effectively.

The CE Mark under MDR - More Than Just a Symbol

The CE mark is not a quality certification issued by the EU, but rather a declaration made by the manufacturer themselves.

The Meaning of the CE mark

By affixing the CE mark to a product, the manufacturer declares that the device:

• Conforms to the applicable requirements of the MDR and any other relevant Union legislation that provides for its affixing.
• Meets high standards for the health and safety of patients and users.
• Can be freely moved within the internal market of the European Union.

In other words, the CE mark is the "commercial passport" that allows your product to access one of the world's largest medical markets.

Requirements for Affixing the CE mark

Affixing the CE mark must adhere to strict rules outlined in Article 20 and Annex V of the MDR:

• Form: The CE marking must conform to the specified design, and if it is reduced or enlarged, the proportions must be respected. The minimum vertical dimension must be 5 mm, unless waived for small-scale devices.
• Placement: The CE mark must be affixed visibly, legibly, and indelibly to the device or its sterile packaging. If this is not possible or warranted due to the nature of the device, it must be affixed to the packaging. The CE mark must also appear in any instructions for use and on any sales packaging.
• Timing: The CE mark must be affixed before the device is placed on the market.

The Role of the Notified Body Identification Number

For medical devices with a risk classification of IIa or higher, the conformity assessment procedure requires the involvement of a Notified Body. In this case:

• The CE marking must be followed by the four-digit identification number of that Notified Body.
• This number clearly indicates which organization supervised and certified the manufacturer's conformity assessment procedure, creating a clear layer of accountability and traceability.
• This number must also be indicated in any promotional material which mentions that a device fulfills the requirements for CE marking.

The EU Declaration of Conformity (DoC) - The Manufacturer's Legal Commitment

If the CE mark is the visible declaration, the EU Declaration of Conformity (DoC) is the legal document that serves as its foundation. This is the document through which the manufacturer formally accepts full responsibility for the product's compliance.

Mandatory Components of the DoC according to Annex IV

The MDR clearly specifies the minimum information that must be included in a DoC in Annex IV. Any omission can render the document invalid. Key components include:

1. Manufacturer and Authorised Representative (AR) information: Name, registered business address, and SRN (if already issued).
2. Statement of Responsibility: A clear statement that the DoC is issued under the sole responsibility of the manufacturer.
3. The Basic UDI-DI of the device.
4. Product Identification: Product name, trade name, product code, or other unambiguous reference allowing for identification and traceability, as well as its intended purpose.
5. Risk class of the device according to the rules in Annex VIII.
6. Statement of Conformity: An affirmation that the device conforms with the MDR and any other relevant EU legislation.
7. References to any standards or CS used against which conformity is declared.
8. Notified Body Information (if applicable): The name and identification number of the Notified Body, a description of the conformity assessment procedure performed, and the identification of the certificate(s) issued.
9. Place and date of issue, name, function, and signature of the person signing for and on behalf of the manufacturer.

Legal Significance: By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes full legal responsibility for compliance with the requirements of the MDR. This document must be continuously updated and kept available for competent authorities for at least 10 years (15 years for implantable devices) after the last device has been placed on the market.

Conclusion: Finalizing the Compliance Journey Professionally

The CE mark and the EU Declaration of Conformity are the two final, inseparable pieces required to legally place your product on the EU market. The mark is the visible passport, while the declaration is the solid legal foundation. Any error in these final documents can lead to market access being denied or delayed, wasting valuable time and resources.

This final stage demands meticulous attention to detail. ITR's Regulatory Supports Service ensures that all documentation, including the final Declaration of Conformity, is prepared correctly and that all requirements for CE marking are met. We help our clients cross the finish line with confidence.

Ensure your product development efforts are recognized with a flawless final compliance process. Contact ITR for consultation and support.

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