For EU CE certification of Class C medical devices, the technical documentation must be comprehensive and adhere to the requirements set out by the EU MDR 2017/745. Here’s a breakdown of the key technical document requirements:

1. Device Description and Specification

• Device Identification: Name, model, and intended use.
• Technical Specifications: Detailed technical description, including design, composition, and manufacturing methods.

2. Design and Manufacturing Information

• Design Documentation: Information on the design process, including design inputs, design outputs, and design verification and validation.
• Manufacturing Process: Details of the manufacturing process, quality control procedures, and facilities.

3. Risk Management

• Risk Analysis: Identification and assessment of potential risks associated with the device.
• Risk Evaluation: Evaluation of the risk level and impact on device safety and performance.
• Risk Control Measures: Mitigation strategies and measures implemented to manage identified risks.

4. Clinical Evaluation

• Clinical Evidence: Data from clinical trials, studies, or literature reviews demonstrating the safety and effectiveness of the device.
• Clinical Evaluation Report (CER): A comprehensive report summarizing the clinical evidence and its relevance to the device.

5. Labeling and Instructions for Use

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

6. Quality Management System (QMS) Documentation

• ISO 13485 Compliance: Documentation demonstrating that the Quality Management System (QMS) complies with ISO 13485 standards.
• QMS Procedures: Records of quality control, audit results, and corrective actions.

7. Declaration of Conformity

• Formal Statement: A Declaration of Conformity asserting that the device complies with EU MDR requirements.

8. Post-Market Surveillance

• Surveillance Plan: A plan for monitoring the device’s performance once 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).
• Biocompatibility and Performance Testing: Results from testing related to biocompatibility and device performance.

Preparation Tips:

• Ensure Completeness: Verify that all documentation is complete and up-to-date.
• Consult Guidelines: Refer to the EU MDR and relevant guidance documents for detailed requirements.
• Engage Experts: Consider consulting regulatory experts or technical writers to ensure compliance.

Contact Us：

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