TABLE OF CONTENTS
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IVDR ANNEX II CLAUSES
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SEC. NO.
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DESCRIPTION
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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
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|
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
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III
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CONCLUSION AND APPROVAL
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