For Class B medical device CE certification, the technical documentation must be comprehensive and demonstrate compliance with the EU Medical Device Regulation (MDR) 2017/745. The key requirements include:

1. Device Description:

• Product Information: Detailed description of the device, including its intended use, function, and operation.
• Technical Specifications: Specifications and drawings, including design and manufacturing details.

2. Design and Manufacturing Information:

• Design Process: Information about the design and development process, including design input, output, verification, and validation.
• Manufacturing Process: Details about the manufacturing process, including equipment, facilities, and quality control procedures.

3. Risk Management:

• Risk Assessment: A risk management report identifying potential hazards associated with the device and the measures taken to mitigate these risks.
• Risk Control Measures: Documentation of risk control measures and their effectiveness.

4. Clinical Evaluation:

• Clinical Data: Evidence supporting the safety and performance of the device, which may include clinical trials, literature reviews, or other relevant studies.
• Clinical Evaluation Report: A report summarizing the clinical data and its relevance to the device’s safety and performance.

5. Labeling and Instructions for Use:

• Product Labels: Labels must include essential information such as the manufacturer's details, device name, and usage instructions.
• Instructions for Use (IFU): Detailed instructions for the safe and effective use of the device, including warnings, contraindications, and handling information.

6. Quality Management System (QMS) Documentation:

• QMS Procedures: Documentation showing compliance with ISO 13485, including quality policies, procedures, and records.
• QMS Records: Evidence of QMS implementation, including design control, production, and post-market surveillance procedures.

7. Post-Market Surveillance Plan:

• Surveillance System: A plan for monitoring the device’s performance once it is on the market, including procedures for reporting adverse events and implementing corrective actions.

8. Declaration of Conformity:

• Document: A formal declaration by the manufacturer stating that the device meets all relevant EU regulations and standards.

9. Technical File Contents:

• All documents listed above should be compiled into a technical file that is organized, clear, and complete, making it ready for review by the Notified Body.

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