What is IVDR Technical Documentation?
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.
IVDR Technical documentation 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.
IVDR Technical documentation for IVD devices shall be prepared by the IVD device manufacturer and the information’s in the technical file or IVDR Technical Documentation 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.
In-Vitro Diagnostic Medical Device (IVDR) Technical Documentation preparation
Want to prepare an IVDR Technical Documentation 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 IVDR Technical Documentation?
- Which Annex of – EU 746/2017 shall be referred for the preparation of IVDR Technical Documentation?
- Who will review and approve the IVDR Technical Documentation?
We at Maven Profcon Services LLP., shall give you all the answers.
In-Vitro Diagnostic Medical device (IVDR) Technical Documentation shall be prepared as per the requirement of Annex II and Annex III of IVDR 2017 / 746.
The IVDR Technical Documentation 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.
The IVDR 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 IVDR 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 IVDR Technical Documentation 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.
