The cost and time required for obtaining EU CE certification for Class I medical devices can vary based on several factors, including the complexity of the device, the need for technical support, and the specific regulatory requirements. Here’s a general overview:

Cost

1. Technical Documentation Preparation: Costs for developing technical documentation, risk assessments, clinical evaluations, and labeling can vary widely. This may involve consulting fees, internal resources, and document preparation costs. Typically, this can range from a few thousand to several tens of thousands of euros, depending on the complexity of the device.

2. Quality Management System (QMS): Implementing a QMS according to ISO 13485 (if applicable) can involve costs for certification and ongoing maintenance. For Class I devices, this might be less intensive but still involves costs related to training and documentation.

3. Regulatory Consulting: If you hire consultants or regulatory experts to assist with the application process, their fees can range from €1,000 to €10,000 or more, depending on the scope of their involvement.

4. CE Marking Fees: For Class I devices, there are generally no fees for the actual CE marking process, but you may incur costs for additional services, such as registration with national authorities, if required.

Time

1. Preparation of Technical Documentation: This step can take from a few weeks to several months, depending on the complexity of the device and the availability of required information.

2. Quality Management System (QMS) Implementation: If not already in place, setting up a QMS and documenting procedures may take a few months. However, this is often a one-time setup.

3. Declaration of Conformity and CE Marking: Once the technical documentation is complete, preparing the Declaration of Conformity and affixing the CE mark typically takes a few weeks.

4. Total Time: The entire process from start to finish, including documentation, preparation, and review, generally takes between 3 to 6 months for Class I medical devices. This timeframe can vary based on how quickly you can gather and prepare necessary documents, the complexity of the device, and whether you encounter any regulatory or technical issues.

Additional Considerations

• Authorized Representative: If you need to appoint an Authorized Representative in the EU, there might be additional costs associated with their services.
• Registration with National Authorities: Some EU member states may require additional registration, which can add to the cost and time.

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