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IVDR Technical Documentation File Contents

The following presents an updated table for the IVDR technical documentation 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

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 – performance evaluation report
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 substances like 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 devices intended for self-testing or near-patient testing
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

Tags: IVDR Technical Documentation File Contents, Technical File Table of Contents, IVDR Technical Documentation, IVDR 2017/746