To obtain EU CE certification for Class C medical devices, you will need to prepare and submit a comprehensive set of materials. Here's a detailed list of required documents and tips on how to prepare them:

Required Materials:

1. Technical Documentation (Technical File or Design Dossier)

   • Device Description: Detailed description of the device, including its intended use, design, and operating principles.
   • Design and Manufacturing Information: Documentation of the design process, manufacturing procedures, and quality control measures.
   • Risk Management File: Detailed risk assessment and management strategies, including risk analysis, evaluation, and mitigation plans.
   • Clinical Evaluation Report (CER): Evidence of clinical safety and performance, including results from clinical trials, literature reviews, or clinical experience.
   • Labeling and Instructions for Use: Compliance with EU requirements, including clear and accurate labeling, user instructions, and warnings.
   • Declaration of Conformity: A formal statement declaring that the device complies with EU MDR requirements.
   • Post-Market Surveillance Plan: Plan for monitoring device performance after it is on the market.

2. Quality Management System (QMS) Documentation

   • ISO 13485 Compliance: Documentation showing that your QMS meets ISO 13485 standards, including procedures, policies, and records.

3. Additional Documents

   • Product Specifications: Detailed technical specifications of the device.
   • Manufacturing Process: Information about the manufacturing process and facilities.
   • Sterilization and Packaging Information: Details on sterilization methods (if applicable) and packaging.

Preparing the Application Documents:

1. Compile Technical Documentation

   • Gather all required documents into a structured technical file or design dossier.
   • Ensure that all sections are complete and that the information is accurate and up-to-date.

2. Prepare Clinical Evaluation

   • Conduct necessary clinical trials or gather clinical data.
   • Prepare a Clinical Evaluation Report (CER) that includes all relevant clinical evidence and analysis.

3. Develop Risk Management File

   • Perform a thorough risk assessment and document risk management processes.
   • Ensure that the risk management file addresses all potential hazards and mitigation strategies.

4. Ensure QMS Compliance

   • Document your Quality Management System (QMS) to show compliance with ISO 13485.
   • Include all relevant procedures, policies, and records.

5. Prepare Labeling and Instructions

   • Ensure that labeling and user instructions are compliant with EU MDR requirements.
   • Include information on safe use, warnings, and any other relevant details.

6. Draft Declaration of Conformity

   • Prepare a Declaration of Conformity that asserts your device's compliance with the EU MDR.
   • Include details of the Notified Body (if applicable) and the device's conformity assessment procedure.

7. Post-Market Surveillance Plan

   • Develop a plan for ongoing monitoring of the device’s performance in the market.
   • Include procedures for reporting adverse events and taking corrective actions.

Submission to Notified Body:

1. Select a Notified Body

   • Choose a Notified Body accredited for Class C devices and ensure they are suitable for your type of device.

2. Submit Application

   • Submit your complete technical documentation, clinical evaluation report, and other required materials to the Notified Body.

3. Respond to Feedback

   • Be prepared to address any questions or additional requirements from the Notified Body during their review process.

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