Validity of the EU Declaration of Conformity: Navigating the Nuances of IVDR Compliance

The EU Declaration of Conformity (DoC) under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 is a formal document wherein a manufacturer asserts compliance of their in vitro diagnostic device (IVD) with the requirements of the regulation.

The IVDR doesn’t stipulate a specific “expiry date” for the EU Declaration of Conformity. That being said, the validity of the DoC is contingent on several factors:

Continued Compliance: The DoC asserts that the product meets the requirements of IVDR. If any changes are made to the product that might affect its compliance, the manufacturer must review the DoC and update it accordingly.

Updates to Standards or Regulations: If there are updates or changes to harmonized standards or the regulation itself, manufacturers must review their products against these changes and ensure continued compliance. The DoC would need to be updated if there’s any impact on the product’s conformity.

Post-market Surveillance: Through post-market surveillance, if any safety or performance issues arise that require changes to the device, the DoC would need re-evaluation and potential updates.

Periodic Review: It’s a best practice for manufacturers to periodically review the DoC, especially in light of changing regulatory landscapes or as part of their quality management system.

Notices from Competent Authorities: If a national competent authority raises concerns about a device’s compliance, the manufacturer may need to revisit and potentially update the DoC

Manufacturers are required to keep the EU Declaration of Conformity and the technical documentation for a period of ten years after the last IVD has been placed on the market, though for implantable devices, it’s 15 years. This ensures traceability and accountability.

The EU Declaration of Conformity (DoC), as stipulated under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, is an essential formal document. Within this declaration, manufacturers affirm and assert that their in vitro diagnostic device, often referred to as IVD, is fully compliant with the standards and requirements laid out by the said regulation.

In essence, while the DoC doesn’t have a specific expiry date, its validity is contingent on the product’s continued compliance with IVDR. Manufacturers must be proactive and vigilant in ensuring this ongoing compliance.

If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.

Leave A Comment