EU DECLARATION OF CONFORMITY
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The EU declaration of conformity shall state that the requirements specified in MDR or IVDR have been fulfilled concerning the device that is covered. The information written in the product DoC must be consistent throughout the Technical Documentation. Like technical documentation, the EU declaration of conformity must be kept up-to-date.
The EU MDR & IVDR Declaration of Conformity (DoC) for the medical devices should include the following info:
- Manufacturers Name
- Manufacturers Address
- Manufacturer SRN
- Authorized Representative Name
- Authorized Representative Address
- Authorized Representative SRN
- Basic UDI-DI & see more
Further, DoC should include:
- Name of the Device
- Intended Use
- Conformity assessment route
- A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
- A statement that the medical device is in conformity with this Regulation
- References to any Common Specifications used (if available)
- Name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued (if applicable)
- Additional info, where applicable
- Name & Function (signed for)
- Place and date of issue
Make sure you write DoC on the company official template with logo and company details.
BioReg experts can write for you the DoC or review your own DoC for compliance.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.