EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745
Overview of Declaration of Conformity:
The EU Declaration of Conformity is an official document through which the manufacturer confirms that the device meets the essential requirements mentioned in Annex IV of Regulation (EU) 2017/745 of the European Parliament and of the Council. By this document, the manufacturer takes the responsibility of ensuring the device’s compliance with the relevant standards and regulations.
Which regulations require an EU DoC?
Article 19 and Annex IV of Regulation (EU) 2017/745 of the European Parliament and of the Council outline key points for the EU declaration of conformity. It must be continuously updated by the manufacturer.
Language requirements for the EU DoC
The EU Declaration of Conformity must be translated into an official Union language or languages required by the Member State(s) where the device is available.
How should the EU DoC be signed and by whom?
The EU Declaration of Conformity should be signed by an authorized person representing the manufacturer. The signature can be either handwritten or electronic, and it is important to include the signatory’s name, position, place, and contact details for accountability and communication purposes.
Can a product have multiple EU DoC?
No, the EU DoC is a single document through which the manufacturer declares that the product meets the applicable requirements of the relevant regulations or directives. It is a comprehensive statement that covers all the essential requirements and standards applicable to the specific product.
What are the consequences of not having a valid EU DoC?
Not having a valid EU DoC can lead to serious consequences. It may prevent manufacturers from placing their products on the market, result in penalties or product recalls, damage their reputation, and potentially lead to legal issues. It is essential for manufacturers to ensure they have a valid and up-to-date declaration to demonstrate compliance and maintain market access.
Content of EU Declaration of Conformity:
Essential Identification Information OF DEVICE
The EU Declaration of Conformity should include the essential identification information of the device. This includes the Name of the Device, registered Trade Name or registered Trade Mark of the device. Additionally, it should contain relevant details such as the product code and catalogue number of the device. Including these identification details in the declaration ensures accurate and clear referencing of the specific device for which the conformity is being declared.
The EU Declaration of Conformity must include the manufacturer’s name and address of their registered place of business. This information is essential for identifying the responsible manufacturer and their contact details. It ensures that regulatory authorities and other stakeholders like users, distributors, and other interested parties can easily communicate with the manufacturer regarding the product’s conformity and compliance.
Single Registration Number-SRN
The EU Declaration of Conformity should include the Single Registration Number (SRN) of the manufacturer and their EU Authorized Representative. The SRN is a unique identifier assigned to the manufacturers, authorised representatives and importers as referred to in Article 31. Including the SRN in the declaration helps in clearly identifying and linking the declaration to the responsible manufacturer. It provides a means of traceability and accountability, ensuring that the declaration can be associated with the correct manufacturer and their corresponding regulatory obligations. This information is important for regulatory authorities, market surveillance, and other stakeholders involved in assessing and verifying compliance with the applicable regulations.
The EU Declaration of Conformity should include the basic UDI-DI (Unique Device Identifier – Device Identifier) as per Annex VI of Regulation (EU) 2017/745. The UDI-DI is a unique identification code assigned to the specific device as part of the Unique Device Identification system. It helps in the traceability and identification of the device throughout its lifecycle.
RESPONSIBILITY OF THE DoC
The EU Declaration of Conformity must be issued solely under the responsibility of the manufacturer. This means that the manufacturer takes full accountability for ensuring that the product meets the requirements specified in the regulations. This emphasizes their commitment to quality, safety, and compliance throughout the product’s lifecycle.
Risk Class of the Device
The EU Declaration of Conformity should include the risk class of the device, determined according to the rules specified in Annex VIII. The risk class indicates the level of potential harm or risk associated with the device. Including this information in the declaration ensures that the appropriate regulatory requirements and safety measures have been addressed.
Common Specification and Harmonized Standards
The EU Declaration of Conformity should include references to any applicable Common Specifications (CS) and a list of applicable harmonized standards used in demonstrating conformity. This information provides transparency and clarity regarding the technical specifications and standards followed by the manufacturer to ensure compliance with the regulations.
EU Authorized Representative’s details
The EU Declaration of Conformity should include the name and address of the EU Authorized Representative. The EU Authorized Representative acts on behalf of the manufacturer in fulfilling certain regulatory obligations within the European Union. By including the name and address of the EU Authorized Representative, the declaration provides a clear point of contact for inquiries, information exchange, and compliance-related matters.
Notified Body Details
If applicable, the EU Declaration of Conformity should include the name and identification number of the notified body involved in the conformity assessment process. Additionally, it should provide a description of the conformity assessment procedure that was followed, along with the certificate numbers issued by the notified body.