EU Declaration of Conformity Medical Device states that the requirements specified in the regulation MDR have been full filled by the predicate device. By this declaration of conformity, manufacturer shall take the responsibility for compliance with the requirements of the regulation and all other Union legislation applicable to the device.
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Annex IV of MDR 2017/745 explains the contents of DOC.
The EU Declaration of Conformity shall contain the following;
- Name, registered trade name or registered trademark of manufacturer
- SRN (Single Registration Number): as per Article 31.
- Authorised representative and the address of their registered place of business.
- statement that the DOC is issued under the sole responsibility of the manufacturer.
- The Basic UDI-DI number.
- Product details- name, product code, catalogue number, intended purpose, variants.
- Classification of Device.
- Conformity assessment route.
- A statement that the device is covered by this declaration is in conformity with Regulation (MDR), if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity.
- Common Specification (CS) and harmonized standards with conformity is declared
- Name and Identification of the notified Body.
- Identification of the certificate issued.
- Place and date.
- Name and designation of the person who signed.
Reference
EU Medical Devices Regulation (MDR 2017/745) April 5, 2017.
Myself Neethu Jino, Sr.Consultant at I3CGlobal, writing this article to share my experiences. If you need more information please write to me, na@i3cglobal.com
Predicate devices are those devices which are already approved, undergone all conformity assessment process and legally placed on the market. During their conformity assessment process manufacturer has drawn declaration of conformity, if product is approved and complying with MDD 93/42/EEC, then it is not mandatory to change DOC as per MDR 2017/745. As DOC drawn as per MDD 93/42/EEC is having its validity for 5 years for medical devices and 15 years for implantable device.
Medical device those which will be placed on market with effective from 26 May 2021 shall draw DOC as per EU MDR 2017/745 Article 19:EU Declaration of conformity, Annexure IV.
In this context, the responder might have had confused the term Predicate devices with Legacy devices. Legacy devices are the ones that have been previously approved as per MDD or AIMDD.
I think what the author meant is that the designated device(s) listed on the DoC should be in conformance with the EU MDR.
In the above article, I just meant as Asha said designated device/ the new medical devices seeking approval.
Certificates issued prior to the implementation of the MDR will have a maximum validity of five years. However, all CE Mark certifications issued before implementation of the new regulations will expire four years after the new regulations. A proposal for a new EU Declaration of Conformity, in accordance with new guidelines and/or standards, should then be developed.
The EU Declaration of Conformity is valid until major product changes are made like manufacturing process change, change in intended purpose, use of new components, and new suppliers. In these cases, the device will consider as a new device and the re-evaluation certification process take place.
The EU Declaration of Conformity must be kept at least ten years after the last date of manufacture of the product, and fifteen years for the implantable device.
I would like to add few more points to the EU Declaration of Conformity.
As per the European Union legislations, the manufacturer of a CE marked product fulfills the requirements as per the harmonized standards and other product specific standards.
When the compliance of a product has been demonstrated by any of the relevant conformity assessment procedures, then the manufacturers draw up an EU declaration of conformity and affix the conformity marking.
By drawing up this EU declaration of conformity, the manufacturer take the legal responsibility for the compliance of the product.
And the manufacturers should keep the technical documentation along with the EU declaration of conformity for a specific period, based on the lifecycle of the product and the level of risk,
after the product has been placed on the market.