EU Declaration of Conformity for Medical Devices and IVDs
What is an EU Declaration of Conformity?
Regarding medical devices and IVDs, the EU Declaration of Conformity states that the requirements specified in the MDR or IVDR for the product concerned have been met.
For this purpose, the manufacturer issues the EU Declaration of Conformity under their sole responsibility. In doing so, the minimum information specified in Annex IV of the regulations, as well as relevant official languages of the Member State(s) where the product is made available, must be observed.
Which Products Require an EU Declaration of Conformity?
In the European Union, there are specific legal requirements for different types of products. This applies not only to medical devices and IVDs, but also to electrical equipment, toys, and many other product types. Compliance with the requirements placed on such a product is certified by the manufacturer by affixing the CE marking (also CE mark) and by issuing the EU Declaration of Conformity.
In addition to this information provided by the manufacturer, formal approval procedures may be necessary in some cases, which the manufacturer cannot carry out under their sole responsibility.
… for Medical Devices
| Class | Declaration of Conformity |
| I | Yes |
| IIa | Yes |
| IIb | Yes |
| III | Yes |
… for IVDs
| Class | Declaration of Conformity |
| A | Yes |
| B | Yes |
| C | Yes |
| D | Yes |
Differences in the Declaration of Conformity: Medical Device vs. IVD
The following table shows a comparison between the requirements of the MDR (EU 2017/745) according to Article 19 and those of the IVDR (EU 2017/746) according to Article 18. These two articles describe the essential requirements for EU Declarations of Conformity.
| MD | IVD |
| (1) The EU declaration of conformity shall state that the requirements laid down in this Regulation concerning the product concerned have been fulfilled. The manufacturer shall keep the EU declaration of conformity up to date. The EU declaration of conformity shall contain at least the information set out in Annex IV and shall be translated into one or more official languages of the Union required by the Member State(s) in which the product is made available. | (1) The EU declaration of conformity shall state that the requirements laid down in this Regulation have been fulfilled. The manufacturer shall keep the EU declaration of conformity up to date. The EU declaration of conformity shall contain at least the information set out in Annex IV and shall be translated into one or more official languages of the Union required by the Member State(s) in which the product is made available. |
| (2) Where, for products, in relation to aspects not covered by this Regulation, an EU declaration of conformity of the manufacturer is also required by other Union legislation to demonstrate compliance with the requirements of that other legislation, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the product. The declaration shall contain all the information required for the identification of the Union legislation to which the declaration relates. | (2) Where, for products, in relation to aspects not covered by this Regulation, an EU declaration of conformity of the manufacturer is also required by other Union legislation to demonstrate compliance with the requirements of that other legislation, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the product. The declaration shall contain all the information required for the identification of the Union legislation to which the declaration relates. |
| (3) By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the product with this Regulation and with all other applicable Union legislation. | (3) By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the product with this Regulation and with all other applicable Union legislation. |
| (4) The Commission is empowered to adopt delegated acts in accordance with Article 115 concerning the amendment of the minimum information to be contained in the EU declaration of conformity set out in Annex IV, taking into account technical progress. | (4) The Commission is empowered to adopt delegated acts in accordance with Article 108 concerning the amendment of the minimum information to be contained in the EU declaration of conformity set out in Annex IV, taking into account technical progress. |
The fundamental requirements for the EU Declaration of Conformity therefore do not really differ between medical devices and IVDs. Even upon closer examination of the required content according to Annex IV of the regulations, essentially no differences can be found.
But why should the declarations of conformity differ significantly from each other? Their purpose is the same in all cases, and therefore, uniform requirements make absolute sense.
Contents of the EU Declaration of Conformity
Based on the minimum information for a medical device from a manufacturer based within the EU, we explain what information you must include in an EU Declaration of Conformity.
| Content | Explanation |
| Name, registered trade name or registered trade mark and — if already issued — SRN of the manufacturer and, where applicable, their authorised representative as referred to in Article 31, and the address of their registered place of business where they can be contacted and where they are actually located; | Identify your company by its name and address. As soon as EUDAMED must be used and you have registered there, a Single Registration Number (SRN) will be assigned to you. From that point on, this unique number for your company will be included in the Declaration of Conformity. |
| a statement that the manufacturer takes sole responsibility for issuing the EU Declaration of Conformity; | “We, Company XY, issue the present EU Declaration of Conformity as the manufacturer of the medical device under our sole responsibility.” |
| the Basic UDI-DI as referred to in Annex VI Part C; | The Basic UDI-DI is neither the UDI-DI nor the UDI-PI. Ensure that you provide the correct Basic UDI-DI. |
| Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the product covered by the EU Declaration of Conformity, such as, where appropriate, a photographic image, and its intended purpose. With the exception of the product or trade name, the information required for identification and traceability may be provided via the Basic UDI-DI referred to in Section 3; | Provide the article number or GTIN (UDI-DI) in human-readable format. State the intended purpose of the product. Ensure that this does not differ between various documents! |
| Risk class of the product in accordance with the rules described in Annex VIII; | The risk class (I, IIa, IIb, III) must be specified. |
| an assurance that the product covered by this declaration complies with the present Regulation and, where applicable, with other relevant Union legislation providing for the issuing of an EU Declaration of Conformity; | “We, Company XY, declare under our sole responsibility as the manufacturer that the product complies with the requirements of EU 2017/745 and, where applicable, other relevant Union legislation that provides for the issuance of an EU Declaration of Conformity.” |
| references to applied specifications for which conformity is declared; | Were common specifications applied according to MDR Article 9? If so, list them here. |
| where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate(s) issued; | If a notified body was involved in the approval process, its identification number must be provided. For example, 0123 for TÜV SÜD. Products of classes Im, Ir, Is, IIa, IIb, III require a notified body. |
| additional information, where applicable; | There are no mandatory requirements here. You can decide what additional information you wish to provide. |
| Place and date of issue of the declaration, name and function of the signatory, and indication of for whom and on whose behalf that person has signed, signature. | The signatory should be legally authorized to sign on behalf of your company. For example, the management. |
Updating the Declaration of Conformity
Both MDR and IVDR require the manufacturer to keep the Declaration of Conformity continuously updated. However, it is not described when an update is necessary. Therefore, as a manufacturer, you must consider how to implement this requirement.
Every manufacturer of medical devices and IVDs must have a quality management system, including a concept for regulatory compliance. Therefore, the quality management system should include requirements for when an update of the Declaration of Conformity is necessary. To cover the requirements regarding different official languages, the necessary translation should also be covered in the QMS.
The update can, for example, be carried out according to the following criteria:
- Update every 2 years.
- Update after significant product change.
- Update upon change of any content in the Declaration of Conformity
One or more Declarations of Conformity?
If a product, for example, is considered an electrical device and must comply with the associated requirements, a Declaration of Conformity is required. If it is considered a medical device, the MDR also requires such a declaration. Are two declarations now to be issued?
No. The MDR clearly stipulates in Article 19(2) that only a single EU Declaration of Conformity must be issued, even if multiple legal acts must be complied with.
When may a Declaration of Conformity be Issued?
Manufacturers of Class I medical devices, without the involvement of a notified body, issue the Declaration of Conformity when the technical documentation has been prepared according to Annexes II and III. Additionally, you must have implemented a quality management system according to Article 10.
Manufacturers of products for which a notified body is involved in the conformity assessment first prepare a draft of the Declaration of Conformity. This draft is attached to the approval documentation. Once the notified body has given its “ok”, the final version can be issued by the manufacturer.
