MDR - annex IV
Original text
Expert opinion
EU Declaration of Conformity
The EU declaration of conformity shall contain all of the following information:
1. Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
The DoC
The DoC is established by the manufacturer as a self-declaration. This declaration must contain certain information given in this annex.
Next to product and trade marks, the single registration number (SRN) from the EUDAMED needs to be on the DoC. In the case a EC REP is used as authorised representative, then this company needs to be named on the DoC as well, next to company contacting information and location.
2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
The DoC must contain a sentence that the responsibility lies with the manufacturer for the DoC. As an example, such a sentence could be: “This Declaration of Conformity for product XY is issued under the sole responsibility of ACME Ltd. as the manufacturer of product XY.”
3. The Basic UDI-DI as referred to in Part C of Annex VI;
The DoC must contain the basic UDI-DI to identify the product. The UDI-DI must match the UDI-DI registered with EUDAMED.
4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
The description of the product in the DoC must be unambiguous. This might be best accomplished by referencing unique descriptors, such as catalogue numbers, product codes, etc. or even a picture of the product. These information is crucial and used to trace the product from company internal references to the UDI-DI and other registered identifiers. Thus, once the UDI-DI is assigned to the product and registered with the EUDAMED, the UDI-DI becomes the tracer for the product.
5. Risk class of the device in accordance with the rules set out in Annex VIII;
The product risk classification is given in Annex VIII of the Medical Device Regulation MDR 2017/745. The self-declared product risk class can be either class I, Is, Im, Ir, IIa, IIb or III.
6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
The DoC needs to contain a statement on the explicit conformity of the product with the Medical Device Regulation MDR 2017/745 and any other applicable directive or regulation. This becomes of special interest for combined or combination products, whereas additional legislations, e.g. Medicinal Product Directive MPD 2001/83/EC become relevant.
7. References to any CS used and in relation to which conformity is declared;
The DoC shall contain any references to Common Specifications (CS), which have been discussed and used to declare the conformity.
8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
For medical devices, the Notified Body (NB) identification number needs to be assigned next to the CE mark, unless the product is of risk class I or Ir.
9. Where applicable, additional information;
Additional information can be placed in this section to render the DoC clearer and potentially more distinct to the product(s) conformity.
10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.
As with every official document, the DoC needs to be dated and signed by a person given the appropriate authority. This should reflect the company signature and authority SOP.
