The process for EU CE certification of medical devices involves several key steps and processes:

1. Device Classification: Determine the classification of your medical device according to the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Classification is based on the intended use, potential risks, and duration of contact with the human body.

2. Identify Applicable Conformity Assessment Procedure: Depending on the classification of your device, choose the appropriate conformity assessment procedure:

   • Class I Devices: Self-certification based on the manufacturer's Declaration of Conformity.
   • Class IIa, IIb, III Devices: Involvement of a Notified Body for conformity assessment.
   • In Vitro Diagnostic Devices: Involvement of a Notified Body for conformity assessment.

3. Prepare Technical Documentation: Develop comprehensive technical documentation that demonstrates conformity with Essential Requirements (for MDR) or General Safety and Performance Requirements (for IVDR). This includes:

   • Device description and specifications
   • Risk analysis and management documentation
   • Clinical evaluation report (for medical devices)
   • Design and manufacturing information
   • Labeling and instructions for use

4. Quality Management System (QMS): Establish and maintain a Quality Management System compliant with ISO 13485:2016 or equivalent standards. The QMS should cover design controls, production processes, risk management, and post-market surveillance.

5. Clinical Evaluation (for medical devices): Conduct a clinical evaluation to demonstrate the safety and performance of the device, based on clinical data and relevant literature.

6. Declaration of Conformity: Prepare and sign the Declaration of Conformity, affirming that your device meets all applicable requirements of the MDR or IVDR.

7. CE Marking: Affix the CE marking to your device once conformity is verified. The CE marking indicates compliance with EU regulations and allows market access within the EU and EEA.

8. Post-Market Surveillance: Implement a post-market surveillance system to monitor the performance of your device after it is placed on the market. This involves collecting and evaluating feedback, complaints, and adverse event reports.

9. Appoint an Authorized Representative (if applicable): If your company is based outside the EU, appoint an Authorized Representative within the EU to act on your behalf regarding regulatory compliance.

10. Submit Documentation to Notified Body (if applicable): If your device requires the involvement of a Notified Body, submit your technical documentation and application for assessment. The Notified Body will review the documentation and conduct audits or tests as necessary.

11. Maintain Compliance: Regularly update your technical documentation and QMS to ensure ongoing compliance with regulatory requirements. Monitor changes in regulations and guidance documents to incorporate updates as needed.

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