Basics | EU

by Regulatory & More Aug 27, 2020

The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17)

EU Declaration of Conformity (DoC)

Article 10 (19) MDR and Article 10 (17) IVDR have almost the same requirements. Minor differences can be highlighted.

They are both related to the EU Declaration of Conformity (EU DoC). The EU DoC is an official declaration by the medical device manufacturer or their authorized representative that the devices concerned are in compliance with all relevant requirements of the MDR or IVDR.

This document declares in substance the devices have been developed, designed and manufactured in compliance with the appropriate conformity assessment requirements dictated in the MDR or IVDR.

As under the MDD and the IVDD, CE marked medical devices must be supplied with an EU DoC under the MDR and the IVDR.

EU DoC Content

The EU DoC must contain relevant information mentioned in the Annex IV of the MDR and in the Annex IV of the IVDR.

Information such as:

Name, registered trade name or registered trade mark and, if already issued, Single Registration Number (SRN), and, if applicable, its authorized representative, and the address of their registered place of business where they can be contacted and their location be established;
A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
The Basic Unique Device Identification Device Identifier (UDI-DI);
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,
Risk class of the device;
A statement that the device that is covered by the present declaration is in conformity with the MDR/IVR and, if applicable, with any other relevant European legislation that provides for the issuing of an EU declaration of conformity;
References to any Common Specification (CS) used and in relation to which conformity is declared;
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;
Where applicable, additional information;
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.

Translated Requirements

Paragraph 1 of MDR Art 19 / IVDR Art 17

The EU DoC shall state that the requirements specified in this Regulation have been fulfilled.

The EU DoC is a living document and the manufacturer shall continuously update it.

The EU DoC shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.

Paragraph 2 of MDR Art 19 / IVDR Art 17

If a manufacturer sells the devices in a Member State requiring also an EU DoC and if this EU DoC requires other aspects not covered by the MDR and the IVDR, then a single EU DoC shall be drawn up in respect of all Union acts applicable to the device.

The EU DoC shall contain all the information required for identification of the Union legislation to which the declaration relates.

Paragraph 3 of MDR Art 19 / IVDR Art 17

When signing the EU DoC, the manufacturer assumes the responsibility for compliance with the requirements of MDR/IVDR and requirements of other European legislation applicable to the device.

Comparison Table

EU MDR – Regulation (EU) 2017/745

EU IVDR – Regulation (EU) 2017/746

The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered.

The manufacturer shall continuously update the EU declaration of conformity.

The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.

The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled.

The manufacturer shall continuously update the EU declaration of conformity.

2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device.

The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates.

3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.

4. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.

4. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.