EU Declaration of Conformity under IVDR

With the introduction of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Union (EU), the landscape for in vitro diagnostic (IVD) devices has been reshaped, bringing many new challenges for manufacturers. One crucial aspect of the IVDR is the EU Declaration of Conformity (DoC). This blog aims to explain the DoC, its significance, the details it encompasses, and the procedure for its implementation under the framework of IVDR.

Understanding the EU Declaration of Conformity (DoC)
The EU DoC is a legally binding document prepared by the manufacturer to declare that their product complies with the applicable EU regulations, in this case, IVDR. It serves as evidence that an IVD device has been designed and manufactured according to the IVDR’s requirements, demonstrating its safety and performance.

Significance of the DoC under IVDR
The DoC plays a vital role in the conformity assessment process under the IVDR. By signing the DoC, the manufacturer takes full responsibility for their device’s conformity with the requirements of the IVDR. It allows the product to bear the CE mark, a symbol of regulatory compliance, which is essential for marketing the product within the European Economic Area (EEA).

Contents of the DoC
The IVDR provides a model structure for the DoC, key information that should be included in the DoC comprises:
– An identification of the device, including its name, model, and type.
– A statement declaring that the DoC is issued under the sole responsibility of the manufacturer.
– Details about the manufacturer, such as the name and the registered address.
– A declaration that the device complies with the applicable requirements of the IVDR.
– The risk class of the device.
– Details of the notified body involved (for Class B, C, and D devices).
– References to relevant harmonised standards or common specifications applied.
– The date of the declaration and the signature of the person responsible on behalf of the organization.

Process of Establishing the DoC
Before issuing the DoC, manufacturers should ensure that they have fully implemented the IVDR’s requirements, which include establishing a Quality Management System (QMS), performing a risk assessment, completing a performance evaluation, and setting up post-market surveillance.

Once these are completed, the manufacturer, or their authorized representative within the EEA, can draft and sign the DoC. For IVDs falling under Class B, C, or D, a notified body must approve the technical documentation and QMS before the DoC can be issued.

Click to read more on who within your organisation should sign the EU Declaration of Conformity

The EU Declaration of Conformity is a critical element of the regulatory process under the IVDR. It signifies that a product meets the regulation’s essential requirements, paving the way for it to bear the CE mark and be marketed in the EU. Manufacturers should be diligent and thorough in the process of establishing the DoC, as it is not just a procedural step but a declaration of their responsibility for the safety and performance of their IVD device. With a clear understanding of the DoC and its implications, manufacturers can better navigate the regulatory journey under IVDR.

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.

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