"Technical documentation" is a very important item in the EU Medical Device Directive. Its purpose is to require enterprises to prepare sufficient technical data and certificates for random inspection by the competent authority or use in case of litigation disputes.

   The Medical Device Directive MDD 93/42/EEC requires that the "Technical File" may contain the following items:

  A, the quality manual and procedure documents of the enterprise

  B, company profile and name and contact information of European authorized representative

  C, CE declaration of conformity (or self-assurance declaration, if the product is used in combination with other equipment, there should be evidence that the overall compliance with the basic requirements)

  1. Brief description of product name, classification and reference standard terms

  2. Product overview (including type and intended use)

  a) History of the product

  b) Technical performance parameters

  c) List of accessories, fittings and other equipment used with the product

  d) Illustrations and samples of products

  e) Raw materials and suppliers used in products

  3. Harmony standards/or other standards for using the product

  4. Risk analysis and assessment conclusions and preventive measures (ISO14971 product service risk analysis report)

  5, production quality control

  a) Product information and control documents (including product production process flow chart)

  b) Description of product sterilization method and validation

  c) Sterilization Validation

  d) Product Quality Control Measures

  e) Description of product stability and shelf life

  6. Packaging and Labeling

  a) Packing material description

  b) Label

  c) Instruction Manual

  7. Technical evaluation

  a) Product inspection report and related literature

  b) Technical overview and authoritative opinions

  8. Potential risk assessment

  a) Product potential risk test report and related literature

  b) Summary of potential risks and authoritative views

  9. Clinical evaluation

  a) Product clinical test report and related literature

  b) Overview of clinical use and authoritative views

  Appendix 1. Product factory inspection report

  Appendix 2, Product Type Test Report

  Appendix 3, Basic Requirements Checklist

  Note: 1. Clinical research (including: physical properties, biochemical, pharmacological, pharmacokinetic and toxicity studies, efficacy testing, sterilization certification, drug compatibility, etc.)

2. Biocompatibility test (A) EN30993 Part I requirements: cytotoxicity, photosensitivity, irritation-intradermal reaction, acute systemic toxicity, pyrogenicity, subacute toxicity, genotoxicity, implantation hemolysis; B) Supporting tests : Chronic poisoning, carcinogenicity, regenerative/growth toxins, biodynamic degradation. )

  3. Clinical data (requires clinical research or description of clinical research)

  4, packaging certificate (EN868)

  5, labels, instructions for use (EN980, EN1041)

  6. Conclusion (acceptance of design archives, statement of interests corresponding to risks)

  The above documents must be written in one of the official EU languages (English, German, French), but the instructions must be written in the language of the user's home country. All documents should be kept for at least five years after the last shipment.