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.
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.
EU Medical Devices Regulation (MDR 2017/745) April 5, 2017.
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