To obtain EU CE certification for medical devices, you need to fulfill several key requirements based on the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Here are the primary requirements:

1. Device Classification: Determine the correct classification of your medical device according to the MDR or IVDR. This classification determines the conformity assessment route and requirements.

2. Conformity Assessment Procedure: Select and follow the appropriate conformity assessment procedure based on the device classification:

   • Class I Devices: Typically subject to self-certification by the manufacturer based on the Declaration of Conformity.
   • Class IIa, IIb, III Devices: Require involvement of a Notified Body for conformity assessment, which may include auditing of quality systems, technical documentation review, and sometimes testing.
   • In Vitro Diagnostic Devices: Generally require Notified Body involvement for conformity assessment, which may include performance evaluation and verification of analytical and clinical performance.

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

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

4. Quality Management System (QMS): Implement and maintain a Quality Management System compliant with ISO 13485:2016 or an equivalent standard. The QMS should cover all aspects of device design, production, 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. This is mandatory for most medical devices and is a critical part of the conformity assessment process.

6. Post-Market Surveillance: Establish a post-market surveillance system to monitor the device's performance and address any issues that may arise after it's placed on the market. This includes collecting and evaluating feedback, complaints, and adverse event reports.

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

8. 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.

9. 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. Notified Body Involvement (if applicable): For devices requiring Notified Body involvement, submit your technical documentation and application for assessment. The Notified Body will review the documentation, conduct audits or tests as necessary, and issue a conformity assessment certificate if the requirements are met.

Contact Us：

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