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IVD Medical Device Technical File

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What is Technical File?

The technical file for In-Vitro Diagnostic medical devices refers to all the documents that an IVD manufacturer has to submit to demonstrate that the product conforms to the applicable and current In-Vitro Diagnostic medical device regulations.

Technical files for such devices shall include, e.g. a detailed description of the device and specification, reference to the previous and similar generation of the device, design information, pre-clinical testing information, performance evaluation, and risk management of the medical device.

Technical file for IVD devices shall be prepared by the IVD device manufacturer and the information’s in the technical file or technical file for In-Vitro Diagnostic medical devices must be presented in a clear, organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the IVD medical device in question.

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In-Vitro Diagnostic Medical Device Technical File (IVDR)

Want to prepare an IVD medical device technical file as per the requirement of MDR 2017/746? If your answer is yes, you probably have lots of questions about the preparation of medical device technical files such as;

  • What shall be covered in the medical devices technical file?
  • Which Annex of -MDR 746/2017 shall be referred for the preparation of medical device technical file according to MDR?
  • Who will review and approve the medical device technical file?

We at Maven Profcon Services LLP., shall give you all the answers.

In-Vitro Diagnostic Medical device technical file shall be prepared as per the requirement of Annex II and Annex III of MDR 2017 / 746.

The technical file shall be submitted to the notified body or competent authority for review and approval for CE Certification. It should be made in the English language or the official language of an EU member state.

Technical documentation, declarations of conformity, and copies of all relevant certificates should now be retained for a period of 10 years after the last device has been placed on the market by the Manufacturers, authorized representatives, and importers of in vitro diagnostic devices.

Economic operators of in vitro diagnostic devices are now responsible for keeping supply chain records for the 10-year retention period noted in Article (10)(7) of these new regulations.

EU IVDR at several instances (Annex IX.6, Annex X.6 and Annex XI.6) require manufacturers (or their authorized representatives) to keep the following records for 10 years after the last device has been placed on the market:

  • EU declaration of conformity;
  • Quality management system documentation;
  • Documentation of procedures and techniques for monitoring, verifying, validating and controlling design;
  • Technical documentation;
  • Copies of EU type-examination certificates; and
  • Certain similar documents.

Lastly, Annex XIV-Chap II.3 requires sponsors of clinical trials for IVD medical devices to keep application forms, investigators’ brochures, and performance study plans and other similar documents for 10 years after the end of any clinical performance study. If the device is placed on the market, the retention period becomes 10 years after the last device has been placed on the market.

Technical File content

Sr. No. Section Description
Section 1 General and Administrative Information
1. 1.0 Table of Content
2. 1.1 Technical file approval team
3. 1.2 General information for the Technical file structure including purpose, scope
4. 1.3 Company Profile
5. 1.3.1 Legal Name & Address of the Manufacture
6. 1.4 Authorized Representative name, address and contact details
7. 1.5 Notified Body Name, Number and Address
Section 2 Technical Documentation
8. 2.1 Device Description And Specification, Including Variants And Accessories
9. 2.1.1
  • Device description and specification
  • Product name or trade name
  • General Description of Device
  • Intended Purpose
  • Indication of use
10. 2.1.1.1
11.
12.
13.
14. 2.1.1.2 Basic UDI-DI
15. 2.1.1.3 Intended patient populations, including details of if applicable;

  • Medical Condition to be diagnostic, treatment, or monitoring
  • Patient selection criteria
  • Indication
  • Contraindications
  • Warning
16. 2.1.1.4 Principle of operation including mode of action
17. 2.1.1.5 Rational for considering the product as medical device
18. 2.1.1.6 Device Classification and Justification for the classification rule as per Annex VIII
19. 2.1.1.7 Explanation of Novel Features
20. 2.1.1.8 Description of Accessories of device
21. 2.1.1.9 A Description of various configurations/variants
22. 2.1.1.10 General description of key components for including software where appropriate required add photograph, drawing and Diagram
23. 2.1.1.11 Description of Raw Materials
24. 2.1.1.12 Technical Specification like feature, dimension
25. 2.2 Reference of Previous and Similar Generations of the device
26. 2.3 Information Supplied by the Manufacturer
27. 2.3.1 Labels: Primary Label, Secondary label and Tertiary label

If you are selling device require specific county language then label should be available on that language

28. 2.3.2 Instruction for use (IFU)

If you are selling device require specific county language then IFU should be available on that language

29. 2.4 Design and Manufacturing Information
30. 2.4.1 Product design File
31. 2.4.2 Manufacturing process and their process validations
32. 2.4.3 Final Product Specification & Testing
33. 2.4.4 Manufacturing Environment Control
34. 2.4.5 Identifying the sites including supplier & subcontractors, where design activities are performed
35. 2.5 Safety & Performance Requirements
36. 2.5.1 List of Applicable Harmonized Standards, Common Specification (CS), Non-harmonized standards, applicable guidelines
37. 2.5.2 General Safety & Performance Requirements (GSPR)
38. 2.5.3 Declaration of Conformity
39. 2.6 Benefit and Risk Analysis & Risk Management
40. 2.7 Product Verification and Validation
41. 2.8 Performance testing
42. 2.8.1 Analytical performance testing
43. 2.8.2 Clinical Performance testing
44. 2.8.3 Electrical Safety and compatibility
45. 2.8.4 Physical, Chemical & Microbiological Compatibility
46. 2.8.5 Software Verification and Validation
47. 2.8.6 Stability or self-life
48. 2.8.7 Sterilization
49. 2.8.8 Performance Evaluation Plan & Report
50. 2.8.9 Summary of Safety & Performance
51. 2.8.10 Post Marketing Activities

  • PMPF Plan & Report
  • PSUR Report
  • PMS Plan & Report
  • Trend Reports
52. 2.8.11 Packaging & Transportation information
53. 2.9 Additional Information is required in specific case:
54. 2.9.1 When device incorporate a substance consider separately as medicine
55. 2.9.2 Device is manufactured by using tissue or cells of human or animal origin
56. 2.9.3 Device that are composed of substance or combination of substance
57. 2.9.4 CMR or Endocrine-Disrupting Substance
58. 2.10 Detail of Device with measuring function
59. 2.11 Details of the device to be connected to other device to achieved its intended purpose
60. 2.12 Revision History
61. 2.13 Conclusion & Approval

Consultant for Technical Documentation

Our regulatory consultants in Maven who are experienced in various fields of Medical & In-vitro Medical Device Regulations are well versed in taking care of technical documentation like Performance evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering file, safety and biological evaluation, and chemical characteristics evaluation.

Our regulatory consultants help you in identifying requirements as per EU IVDR, identification of CE assessment route according to the class of the device, helps in performance evaluation and also in post-marketing activities, risk analysis, and quality management implementation.

Maven as a developing medical device and In-Vitro Diagnostic medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us

  • Gap analysis of Medical Device Technical file as per the requirement of EU-IVDR
  • Identification and classification of the In-Vitro Diagnostic medical device as per EU IVDR
  • Help in selection of conformity route of assessment and Notified body
  • Preparation and Review of the technical documents as per EU IVDR.
  • Help to maintain and update the technical file post certification.

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