For EU CE certification of Class C medical devices, the technical documentation must be thorough and comply with the requirements of the EU Medical Device Regulation (MDR) 2017/745. The key requirements include:

1. Device Description

• General Description: Detailed information about the device, including its intended purpose, functionality, and how it works.
• Device Classification: Justification of the device’s classification as Class C.

2. Design and Manufacturing Information

• Design Documentation: Details of the design process, including design inputs, outputs, and changes.
• Manufacturing Information: Description of the manufacturing processes, quality control procedures, and facilities.

3. Risk Management

• Risk Analysis: Comprehensive risk assessment identifying potential hazards and associated risks.
• Risk Control: Measures and controls implemented to mitigate identified risks.
• Risk Management Report: Documentation showing how risks are managed throughout the device’s lifecycle.

4. Clinical Evaluation

• Clinical Data: Evidence from clinical trials, studies, or literature demonstrating the device’s safety and performance.
• Clinical Evaluation Report (CER): A detailed report summarizing the clinical evidence and its relevance to the device.

5. Labeling and Instructions for Use

• Labeling: Information on the device label, including device name, intended use, and warnings.
• Instructions for Use: Detailed user instructions covering installation, operation, and maintenance.

6. Quality Management System (QMS) Documentation

• ISO 13485 Compliance: Evidence that your QMS adheres to ISO 13485 standards.
• QMS Procedures: Documentation of quality management procedures, including audit results and corrective actions.

7. Declaration of Conformity

• Formal Declaration: A statement declaring that the device conforms to the EU MDR requirements.

8. Post-Market Surveillance

• Surveillance Plan: A plan for monitoring the device’s performance and safety after it is on the market.
• Adverse Event Reporting: Procedures for reporting adverse events and taking corrective actions.

9. Other Supporting Documents

• Sterilization and Packaging: Information on sterilization methods and packaging (if applicable).
• Performance Testing: Results from tests related to the device’s performance and safety.

Preparation Tips:

• Ensure Completeness: Verify that all documentation is complete and complies with the MDR.
• Consult Guidelines: Refer to EU MDR and relevant guidance documents for detailed requirements.
• Engage Experts: Consider consulting regulatory experts to ensure your documentation meets all regulatory expectations.

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