For EU CE certification of Class D medical devices, the technical documentation, also known as the Design Dossier, must be comprehensive and detailed to demonstrate compliance with the EU Medical Device Regulation (MDR) 2017/745. Here’s a breakdown of the key requirements for the technical documentation:

1. Device Description and Specifications

• General Information: Detailed description of the device, including its intended purpose, design, and operational principles.
• Classification: Justification of the device's classification as Class D and its intended use.

2. Design and Manufacturing Information

• Design Specifications: Detailed information about the design and development of the device.
• Manufacturing Processes: Description of manufacturing processes, including equipment, procedures, and quality controls.
• Materials: Information on the materials used in the device and their biocompatibility.

3. Risk Management

• Risk Analysis: Identification of potential hazards and associated risks, and the measures taken to mitigate these risks (ISO 14971 compliance).
• Risk Assessment Report: Documentation of the risk assessment process and results.

4. Clinical Evaluation

• Clinical Data: Evidence of the device’s safety and performance, including clinical trials, studies, or literature reviews.
• Clinical Evaluation Report: Summary of the clinical evaluation process, data, and conclusions.

5. Performance and Safety Testing

• Test Reports: Results from performance and safety testing, including preclinical tests, biocompatibility studies, and any other relevant evaluations.
• Standards Compliance: Evidence of compliance with relevant harmonized standards for safety and performance.

6. Quality Management System (QMS)

• ISO 13485 Documentation: Proof of compliance with ISO 13485, including QMS procedures, policies, and records.
• Quality Control: Documentation of quality control procedures and practices.

7. Labeling and Instructions for Use

• Device Labeling: Labels must include required information such as the CE mark, device name, manufacturer details, and any warnings or precautions.
• Instructions for Use (IFU): Clear and comprehensive instructions for safe and effective use of the device, including any contraindications, warnings, and maintenance instructions.

8. Post-Market Surveillance

• Post-Market Surveillance Plan: A plan detailing how the device’s performance will be monitored after it is placed on the market.
• Adverse Event Reporting: Procedures for reporting and managing adverse events and device incidents.

9. Declaration of Conformity

• Declaration Document: A formal statement from the manufacturer declaring that the device complies with all applicable EU regulations and standards.

10. Additional Documentation

• Risk Management File: Documentation showing how risks are managed throughout the device lifecycle.
• Change Control Records: Records of any changes made to the device or its manufacturing process, and how these changes are managed.

Preparation Tips

• Organization: Ensure the technical documentation is well-organized and includes a table of contents and index for easy navigation.
• Compliance: Follow MDR requirements and harmonized standards closely to ensure all documentation is complete and accurate.
• Consultation: Consider consulting with regulatory experts or consultants to ensure your documentation meets all requirements.

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