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IVDR Technical File Contents
The following presents an updated table for the IVDR technical file contents, encompassing the requirements outlined in IVDR 2017/746 ANNEX II. This comprehensive structure aims to facilitate easy reference to relevant clause and sub-clause numbers
TABLE OF CONTENTS |
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| IVDR ANNEX II CLAUSES | SEC. NO. | DESCRIPTION |
0 |
a |
INTRODUCTION |
| 0 | b | Purpose |
| 0 | c | Scope |
| 0 | d | Issue register & revision history |
0 |
I |
ADMINISTRATIVE INFORMATION |
| 0 | i | Legal name and address |
| 0 | ii | Person responsible for regulatory compliance (PRRC) |
| 0 | iii | European Union authorized representative |
| 0 | iv | Notified body |
Annex II |
II |
TECHNICAL INFORMATION |
| 1 | 1 | Device description and specification, including variants and accessories |
| 1.1 | 1.1 | Device description and specification |
| 1.1a | 1.1.1 | Product name or trade name |
| 1.1a | 1.1.2 | General description of the device |
| 1.1b | 1.1.3 | Product identification |
| 1.1c | 1.1.4 | Intended purpose |
| 1.1c | 1.1.5 | Intended users |
| 1.1c | 1.1.6 | Intended patient population |
| 1.1d | 1.1.7 | Description of the principle of assay method or the principles of operation |
| 1.1e | 1.1.8 | Medical device rationale |
| 1.1f | 1.1.9 | Device classification and justification |
| 1.1g | 1.1.10 | Description of components and description of reactive ingredients of relevant components |
| 1.1h | 1.1.11 | Description of the specimen collection and transport materials |
| 1.1i | 1.1.12 | Description of assay characteristics (for instruments of automated assays) |
| 1.1j | 1.1.13 | Description of instrumentation characteristics (for automated assays) |
| 1.1k | 1.1.14 | Description of any software to be used with the device |
| 1.1l | 1.1.15 | Description of variants/configurations |
| 1.1m | 1.1.16 | Description of accessories/other devices/products that are not devices, to be used in combination |
| 1.2 | 1.2 | Reference to previous and similar generations of the device |
| 1.2a | 1.2.1 | An overview of the previous generation |
| 1.2b | 1.2.2 | An overview of identified similar devices |
| 2 | 2 | Information to be supplied by the manufacturer |
| 2a | 2.1 | Labels |
| 2b | 2.2 | Instructions for use |
| 3 | 3 | Design and manufacturing information |
| 3.1 | 3.1 | Design information |
| 3.2 | 3.2 | Manufacturing information |
| 3.2a | 3.2.1 | Manufacturing processes |
| 3.2a | 3.2.2 | Final product specification and testing |
| 3.2a | 3.2.3 | Manufacturing environmental controls |
| 3.2b | 3.3 | Suppliers and subcontractors |
| 4 | 4 | General safety and performance requirements |
| 4 | 4.1 | The general safety and performance requirements |
| 4 | 4.2 | Declaration of conformity |
| 4a, 4b | 4.3 | List of applied legislation |
| 4a, 4b | 4.4 | List of applied guidelines |
| 4c, 4d | 4.5 | List of applied harmonized standards |
| 4c, 4d | 4.6 | List of applied non-harmonized standards |
| 5 | 5 | Benefit-risk analysis and risk management |
| 5a | 5.1 | The benefit-risk analysis |
| 5b | 5.2 | Risk management |
| 6 | 6 | Product verification and validation |
| 6.1 | 6.1 | Information on analytical performance of the device |
| 6.1.1 | 6.1.1 | Specimen type |
| 6.1.2 | 6.1.2 | Analytical performance characteristics |
| 6.1.2.1 | 6.1.2.1 | Accuracy of measurements |
| 6.1.2.2 | 6.1.2.2 | Analytical sensitivity |
| 6.1.2.3 | 6.1.2.3 | Analytical specificity |
| 6.1.2.4 | 6.1.2.4 | Metrological traceability of calibrator and control material values |
| 6.1.2.5 | 6.1.2.5 | Measuring range of the assay |
| 6.1.2.6 | 6.1.2.6 | Definition of assay cut-off |
| 6.1.3 | 6.1.3 | The analytical performance report |
| 6.2 | 6.2 | Information on clinical performance and clinical evidence |
| 6.3 | 6.3 | Stability (excluding specimen stability) |
| 6.3.1 | 6.3.1 | Claimed shelf-life |
| 6.3.2 | 6.3.2 | In-use stability |
| 6.3.3 | 6.3.3 | Shipping stability |
| 0 | 6.4 | Usability |
| 6.4 | 6.5 | Software verification and validation |
| 6.5 | 6.6 | Additional information required in specific cases |
| 6.5a | 6.6.1 | Sterile devices |
| 6.5b | 6.6.2 | Devices of biological origin |
| 6.5c | 6.6.3 | Devices with measuring function |
| 6.5d | 6.6.4 | Devices connected to other equipment |
| 0 | 6.6.5 | Devices containing CMR or endocrine-disrupting substances |
| 0 | 6.6.6 | Devices emitting radiation |
| 0 | 6.6.7 | Electrical safety and electromagnetic compatibility (EMC) |
| 0 | 6.6.8 | Protection against mechanical and thermal risks |
| 0 | 6.6.9 | Protection against risks associated with self-testing devices |
| 0 | 6.6.10 | Summary of safety and performance (SSP) |
| 0 | 6.6.11 | Manufacturer declaration |
| 1 | 6.7 | Post-marketing activities |
| 1a | 6.7.1 | Post-market surveillance |
| 1b | 6.7.2 | Post-market performance follow-up |
| 2 | 6.7.3 | Periodic safety update report |
| 0 | 6.7.4 | Vigilance |
0 |
III |
CONCLUSION AND APPROVAL |