For EU CE certification of Class I medical devices, the technical documentation must be comprehensive and align with the requirements set forth by the EU Medical Device Regulation (MDR) 2017/745 or the In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Here’s a detailed list of the required technical documents:

1. Device Description and Specification

• Device Details: Include the device name, model, and version.
• Intended Use: Describe the intended purpose and clinical indications.
• Device Design and Function: Provide detailed descriptions, including how the device works and its key features.

2. Design and Manufacturing Information

• Design Documentation: Include design drawings, specifications, and descriptions of design features.
• Manufacturing Process: Detail the manufacturing processes, materials used, and controls in place to ensure quality.
• Quality Control Procedures: Document quality control measures and testing procedures.

3. Risk Management

• Risk Assessment: Conduct a risk assessment according to ISO 14971 to identify and evaluate potential risks associated with the device.
• Risk Control Measures: Describe measures implemented to control identified risks.

4. Clinical Evaluation

• Clinical Evidence: Provide evidence demonstrating the device’s safety and performance. This may include:
  • Clinical Data: Data from clinical studies, if applicable.
  • Literature Review: Reviews of scientific literature relevant to the device’s intended use and performance.
  • Equivalent Devices: Information on similar devices, if applicable.

5. Instructions for Use (IFU) and Labeling

• User Manuals: Develop clear and comprehensive instructions for use, including device operation, maintenance, and disposal.
• Labeling: Ensure labels include necessary information such as:
  • CE mark.
  • Manufacturer’s details (name and address).
  • Device name and model.
  • Warnings and precautions.

6. Declaration of Conformity

• Document Content: Prepare the Declaration of Conformity, which should include:
  • Device details.
  • Manufacturer’s details.
  • Compliance with applicable EU regulations and harmonized standards.
  • Date and signature of the authorized person.

7. Quality Management System (QMS) Documentation (if applicable)

• ISO 13485: Although not always mandatory for Class I devices, documentation related to the Quality Management System may be necessary, especially if you are establishing or maintaining one.

8. Post-Market Surveillance

• Post-Market Plan: Outline a plan for post-market surveillance to monitor device performance and manage any potential issues.
• Complaint Handling: Document procedures for handling and investigating complaints and adverse events.

9. Risk Management File

• Documentation: Maintain a risk management file that includes risk analysis, evaluation, and mitigation strategies.

10. Clinical Evaluation Report

• Report Content: If applicable, prepare a clinical evaluation report summarizing the data and evidence supporting the device’s safety and performance.

11. Technical File

• File Structure: Organize all documentation into a technical file that can be reviewed by regulatory authorities if necessary. This file should be updated regularly and kept available for a specified period after the device is placed on the market.

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