In the EU CE certification process for medical devices, technical documentation plays a critical role in demonstrating compliance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Here are the key requirements for technical documentation:

General Requirements:

1. Comprehensive Documentation: The technical documentation must be comprehensive and sufficiently detailed to demonstrate conformity with the applicable requirements of the MDR or IVDR.

2. Language: The documentation should be in an official language of the EU Member State where the Notified Body is located or in a language accepted by the Notified Body.

3. Traceability: Ensure that all documents are traceable, with references to applicable standards, regulations, and guidelines.

4. Updates and Revisions: Maintain the documentation updated with any changes or revisions to the device design, manufacturing processes, risk management, clinical evaluation, and post-market surveillance.

Specific Requirements:

The specific contents of the technical documentation vary based on the device classification and conformity assessment route (e.g., self-certification or involvement of a Notified Body). Here are the typical components:

1. Device Description:

   • Intended Use: Clear description of the device's intended purpose and target population.
   • Specifications: Detailed specifications of the device, including design drawings, dimensions, materials used, and components.

2. Design and Manufacturing Information:

   • Design Validation: Evidence that the design meets the specified requirements and is validated through design verification and validation activities.
   • Manufacturing Process: Detailed description of manufacturing processes, including assembly, testing, sterilization (if applicable), and quality control measures.

3. Risk Management File:

   • Risk Analysis: Comprehensive risk analysis identifying potential hazards associated with the device throughout its lifecycle.
   • Risk Controls: Documentation of risk controls implemented to mitigate identified risks, including design features, protective measures, and safety mechanisms.

4. Clinical Evaluation Report (for medical devices):

   • Clinical Data: Compilation of clinical data demonstrating the safety and performance of the device, obtained through clinical investigations, literature reviews, and post-market surveillance data.
   • Clinical Evaluation: Evaluation of clinical data to assess conformity with the Essential Requirements (MDR) or General Safety and Performance Requirements (IVDR).

5. Labeling and Instructions for Use:

   • Labeling: Compliance with EU labeling requirements, including symbols, warnings, and instructions for use.
   • Instructions for Use: Clear and concise instructions for the safe and effective use of the device by healthcare professionals and/or end-users.

6. Quality Management System (QMS) Documentation:

   • QMS Overview: Description of the QMS implemented by the manufacturer, including organizational structure, responsibilities, and procedures.
   • Quality Plans: Documentation of quality plans, including design controls, production controls, purchasing controls, and process validation.

7. Declaration of Conformity (DoC):

   • Signed Declaration: A formal declaration signed by the manufacturer or Authorized Representative (if applicable), affirming that the device complies with all applicable requirements of the MDR or IVDR.

Additional Considerations:

• Post-Market Surveillance Plan: Include a plan for monitoring the device's performance after it is placed on the market, including methods for collecting and evaluating post-market data.

• Clinical Data Requirements: Ensure that clinical data and clinical evaluation are proportionate to the device's risk class and intended use.

• Documentation Organization: Structure the technical documentation logically and ensure it is easily navigable for review by regulatory authorities or Notified Bodies.

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