Applying for EU CE certification for Class I medical devices involves several key steps. Here’s a general outline of the process:

1. Determine Classification

• Confirm that your device is classified as Class I according to the EU MDR (Medical Device Regulation) 2017/745 or the EU IVDR (In Vitro Diagnostic Device Regulation) 2017/746 if it’s an IVD.

2. Ensure Compliance with EU Regulations

• Medical Device Regulation (MDR) 2017/745: For most medical devices.
• In Vitro Diagnostic Device Regulation (IVDR) 2017/746: For in vitro diagnostic devices.

3. Prepare Technical Documentation

• Device Description: Details about the device and its intended use.
• Design and Manufacturing Information: Drawings, specifications, and descriptions.
• Risk Management: Risk assessment according to ISO 14971.
• Clinical Evaluation: Clinical evidence or literature review demonstrating safety and performance.
• Instructions for Use: User manuals and labeling requirements.
• Quality Management System (QMS): Documented procedures in line with ISO 13485 if required.

4. Create a Declaration of Conformity

• Draft a Declaration of Conformity stating that the device meets all the relevant EU requirements.

5. Affix the CE Marking

• Once all documentation is prepared and the Declaration of Conformity is complete, you can affix the CE mark to your device.

6. Register the Device

• National Competent Authorities: In some cases, you may need to register your device with the competent authorities in the EU member states where you plan to sell it.

7. Post-Market Surveillance

• Establish procedures for monitoring the device's performance and reporting any adverse events.

8. Maintain Documentation

• Keep all documentation available for review and audits, including the technical documentation and post-market surveillance reports.

Additional Considerations

• Authorized Representative: If you are not based in the EU, you must appoint an Authorized Representative in the EU.
• Labeling Requirements: Ensure your device's labeling meets EU regulations, including the CE mark and required information.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn