Understanding the EU Declaration of Conformity: Who Should Sign for IVDR Compliance?

The EU Declaration of Conformity (DoC) is a document wherein a manufacturer declares that their product complies with the essential requirements of the applicable European Directives or Regulations. The In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 is the EU legislation pertaining to in vitro diagnostic medical devices.

The responsibility for signing the EU DoC, under IVDR or any other EU regulation, primarily falls on the manufacturer. Specifically referring to IVDR:

Manufacturer: This is the main entity responsible for the design, manufacture, packaging, and labeling of the product. They ensure that the product meets essential requirements and maintain the technical documentation. The manufacturer should sign the DoC and affix the CE mark to the product, implying its conformity.

Authorized Representative: If the manufacturer is not based within the EU, they must designate an EU Authorized Representative. This representative can act on behalf of the manufacturer and might be involved in regulatory compliance issues. While the primary responsibility remains with the manufacturer, the Authorized Representative also plays a role in ensuring conformity.

Other entities: Depending on contractual obligations, other entities, like importers or distributors, might have roles in the compliance process. However, the main responsibility for the DoC lies with the manufacturer or their designated EU representative.

The EU Declaration of Conformity (DoC) is a critical document that demonstrates a product’s compliance with European regulations. The person who signs the DoC should hold a position that gives them the authority to bind the company. This ensures that the company is held accountable for the claims made in the DoC.

Typically, the person signing the DoC is in a senior management role. While the specific position can vary from one company to another, some of the commonly accepted roles include:

CEO (Chief Executive Officer): As the highest-ranking executive in a company, the CEO has the ultimate authority to ensure and declare that the company’s products meet all regulatory requirements.

COO (Chief Operating Officer): This person oversees the company’s day-to-day administrative and operational functions, making them well-placed to confirm compliance.

VP or Director of Regulatory Affairs: These individuals are directly responsible for ensuring that products meet regulatory standards. Given their specific expertise and understanding of regulatory requirements, they are often the ones signing the DoC.

Quality Assurance or Compliance Manager/Director: Individuals in these roles ensure that the company’s products and processes adhere to established quality standards and regulatory requirements.

General Counsel or Legal Director: In some cases, especially when there may be legal implications, a senior legal officer or executive might sign the DoC.

It’s essential that the person signing the DoC has a comprehensive understanding of the regulatory landscape, the specific requirements of the applicable regulations (like the IVDR, MDR, etc.), and the implications of signing such a document. Additionally, they must have the authority within the company to represent and commit the company to such a declaration.

Companies should ensure that their internal procedures clearly define who is authorized to sign the DoC. If there’s any uncertainty, consulting with a regulatory affairs specialist or legal counsel is advisable.

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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