EU Declaration of Conformity

In this article you will learn,

• how to write a declaration of conformity,
• what mistakes you should avoid in order to ensure there are no negative legal consequences, and
• what you should pay special attention to with the change to the EU regulations (MDR, IVDR).

1. Contents of a declaration of conformity

Annex IV of the MDR specifies what a declaration of conformity must contain:

1. Information about the device
   1. Name of the device, registered trade name or registered trade mark
   2. Unique reference, e.g., the name, product code, or catalog number, where appropriate also a photo
   3. Intended purpose of the device
   4. The device’s Basic UDI-DI
   5. The device´s risk class
2. Information on the conformity of the device
   1. A statement from the manufacturer that the EU Declaration of Conformity is issued under its sole responsibility
   2. A statement that the device conforms with the requirements of the MDR “and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU Declaration of Conformity”
   3. References to any CS used and in relation to which conformity is declared
   4. Name and identification number of the notified body involved in the conformity assessment procedure
3. Information about the manufacturer
   1. Name and address of the manufacturer and/or its authorized representative
   2. If already issued, the SRN of the manufacturer and its authorized representative  
4. Other
   1. Place and date of issue
   2. Name and function of the person signing the declaration
   3. Signature

2. Scope of a declaration of conformity

Don’t declare conformity for an unspecified number of devices. Wording that doesn’t contain any restrictions in terms of applicability does not comply with regulatory requirements such as those of the German ZLG.

The declaration of conformity must refer to:

1. a clearly defined batch or serial number or software version and
2. a limited time period.

Point a) comes from the requirement for “traceability.” The Blue Guide explains what the legislator means by traceability:

The declaration “must contain sufficient information to enable all products covered by it to be traced back to it.” […] “A number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number.” 

Blue Guide, Section 4.4 on declarations of conformity

Therefore, the law (MDR/IVDR) actually only provides for option a). Since this is impractical in medical technology and since a large number of serial/batch numbers are often produced, the ZLG has authorized option b) in the Guidance Document 3.9 A4.

While the ZLG document is only written for the existing guidelines, the Johner Institute assumes that this is still applicable with the MDR. However, the requirements for the declaration of conformity content described in the ZLG document have been partially superseded by the precise requirements of the MDR.

3. Transition to the MDR

3.1 General

Article 122 of the MDR repealed the MDD (Directive 93/42/EEC) effective May 26, 2021. For legacy devices that continue to be placed on the market in accordance with the transitional provisions of the MDR in Article 120 (3) until the end of the aforementioned transition periods under the MDD, a new EU declaration of conformity in accordance with Article 19 of the MDR is not yet required, even if certain requirements of the MDR have already had to be implemented for legacy devices since its date of application.

This is now clarified in the guidance document MDCG 2021-25. The latest revision of the guideline excludes the applicability of Article 19 of the MDR. It clarifies that the declaration of conformity of legacy devices must refer exclusively to Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD).

Manufacturers can also declare conformity with Article 120 of the MDR to show that they meet the conditions for extending the transition periods and are still allowed to place the devices on the market. This can be particularly helpful for approvals in target markets outside the Union. This declaration must always refer to the initial EC declaration of conformity issued before May 26, 2021.

3.2 What about (non-significant) product changes?

Legacy devices must continue to comply with the MDD and AIMDD provided that no significant changes are made to the design and intended purpose. Opinions have so far differed greatly on whether a declaration of conformity for legacy devices may be updated in the case of non-significant changes.

The guidance document MDCG 2021-25 finally provides clarity in this case as well:

“Where the manufacturer updates its DoC to reflect changes regarding information provided in the declaration (e.g. changes concerning the address, the authorised representative, or the validity date) the manufacturer should add a reference to the DoC which was drawn up for the legacy device before 26 May 2021. In addition, traceability of all versions of the DoC needs to be ensured.”

MDCG 2021-25 Rev. 1, Footnote 9

It is, therefore, clear that an update of the declaration of conformity is possible for non-significant changes if the following conditions are met:

• In the updated declaration of conformity, the manufacturer must refer to the declaration of conformity that was initially issued for the legacy devices before May 26, 2021.
• If the declaration of conformity is updated multiple times, the traceability of all versions must be ensured.

This clarification regarding the declaration of conformity should end discussions with regulatory authorities, notified bodies, or other economic operators.

4. Requirements for other stakeholders

The MDR defines the actions required from a variety of stakeholders with regard to the declaration of conformity:

Stakeholder	Activity	Article
Responsible person	Making sure that the EU Declaration of Conformity has been prepared and is up to date	Article 15
Importers	Checking that an EU Declaration of Conformity has been issued for the device	Article 13
Distributors	Checking that an EU Declaration of Conformity has been issued for the device	Article 14

Therefore, you should make sure to do the following:

1. Adapt your SOPs, work instructions, and contracts, e.g., quality assurance agreements.
2. Inform these stakeholders of their roles/obligations.
3. Ensure their competencies.
4. If necessary, check that the tasks, e.g., for internal audits, have been performed entirely and correctly.

5. Additional tips for creating a declaration of conformity

1st tip: Define the responsibility for the declaration

The civil and criminal consequences of unauthorized or incorrect conformity assessment are wide ranging. Therefore, define – for example, in a standard operating procedure in your QM system – who is responsible for creating this important document and who is responsible for its release. For small and medium-sized companies, this can be the head of the company.

2nd tip: Choose the right time to create the declaration of conformity

You cannot declare conformity until you have gone through the conformity assessment procedure for the device. Depending on the class of the medical device, this may require an annex certificate from the notified body.

However, you must have declared conformity before you affix the CE mark to your device.

3rd tip: Define the device precisely

A declaration of conformity must refer to exactly one identifiable device or device type. This identifiability is generally provided by

• the name of the device,
• the product code, or
• another reference.

One declaration of conformity for a device class is not possible.

4th tip: Keep the declaration of conformity ready

As a manufacturer, you have to maintain the conformity assessment as part of the technical documentation and be able to present it at any time upon request. A lot of manufacturers even publish them on their website.

Importers, distributors, and authorized representatives must have the declarations of conformity.

5th tip: Don’t reference any standards

Be careful not to reference “entire” standards in the declaration of conformity because, if you do, you will have to comply with the entire standard, unless you have documented elsewhere why certain parts of the standard in question are not applicable.

In addition, you would have to change the declaration of conformity every time a standard changes. According to EK Med, specifying standards is optional.

6. Conclusion

The EU Declaration of Conformity is a short document but is very important from a regulatory point of view. Please differentiate this document from other certificates and declarations you complete for your customers. Manufacturers are under the obligation to give the declaration of conformity to importers, distributors, and authorized representatives.

It is very easy to make mistakes when creating and handling this document. And that often leads to regulatory problems during audits, inspections, or reviews of the technical documentation by the authorities and notified bodies. Competitors also use these errors to pester you with warnings.

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Change history:

• 2025-01-27: Update of chapter 3 in consideration of the latest recommendations of the guidance document MDCG 2021-25 Rev. 1, change of numbering of individual chapters
• 2024-05-13: In the list in chapter 1, the batch number has been removed from the scope. Incorrect link to Annex IV of the MDR corrected.
• 2024-02-25: Definition inserted at the beginning of the article, chapters renumbered, editorial improvements
• 2021-05: The article from 2017 was completely revised.