What is an EU Declaration of Conformity (DoC)?
EU Declaration of Conformity (DoC) formally known as the CE Declaration of Conformity is a mandatory one-page letter or document showing that the product’s compliance with the CE marking directives or regulations applicable to EU Law.
If the Manufacturer or the Authorized Representative signs the EU Declaration of Conformity, it makes them liable for the product’s compliance and the Manufacturer or the Authorized Representative must take full responsibility for the same.
Before launching a product to the European market, An EU Declaration of Conformity is required.
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What is an EU Declaration of Conformity for Medical Devices?
According to the Medical Device Reporting (MDR), the EU Declaration of Conformity is an essential document for medical devices that shows the product standard, safety, and performance set by the EU government.
The EU Declaration of Conformity for Medical Devices authenticates the product’s reliability and verifies that it satisfies the MDR’s set standards.
Requirements of EU Declaration of Conformity for Medical Devices.
EU government state that the EU Declaration of Conformity must be translated into one of the official languages of the European Union, regarding each state manufacturer may require to translate the EU Declaration of Conformity into the official language of the particular state.
Content of EU Declaration of Conformity.
- The manufacturer’s or the authorized representative’s (if applicable) name and address must be provided.
- The product’s identification number, catalog number, trade name, and product code must be mentioned for better identification and traceability of the product.
- A statement stating that the manufacturer or authorized representative is solely responsible for the EU Declaration of Conformity.
- All standards and technical specifications of the product must be complied with in a precise and clear way in EU legislation.
- The job description, or an equivalent form of identification, of the authorized person, along with their signature, must be included.
Why Declaration of Conformity for Medical Devices is Important?
If you are a medical device manufacturer, you cannot launch a medical device without a valid declaration of conformity. It is an important document that displays a manufacturer’s commitment to delivering safe and effective devices that fulfill regulatory standards.
The Declaration of Conformity is essential for assuring regulatory compliance, patient safety, maintaining quality standards, getting market access, and enabling medical device traceability and responsibility.
EU Declaration of Conformity Template.
For the EU Declaration of conformity template visit the official EU website. Link
How can Operon Strategist help with the EU Declaration of Conformity for Medical Devices?
Operon Strategist is a medical device regulatory consultant for CE marking for medical devices and guidance to manufacturers in the healthcare industry for strategic development.
We assist manufacturers in the creation and maintenance of the EU Declaration of Conformity, ensuring that it has all the necessary information such as product identity, manufacturer details, compliance with applicable EU regulations, and more.
We specialize in assisting clients in obtaining regulatory licenses and certifications at both the national and international levels, and we provide global regulatory compliance support and consultancy for medical devices in various countries.
Contact us for any regulatory compliance consulting.
