Sunday, 28 March 2021

IVDR Technical Documentation

European manufacturer need to address the General safety and performance requirements(GSPRs) to comply IVDR 2017/746. Technical documentation is created to address the GSPRs.

IVDR Annex II & III provides the technical documentation structure.


European manufacturer need to address the General safety and performance requirements(GSPRs) to comply IVDR 2017/746. Technical documentation is created to address the GSPRs.

IVDR Annex II & III provides the technical documentation structure.

1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

1.1. Device description and specification

a)     Product name, description, intended purpose and  intended users

b)     Product identification including basic UDIDI

c)      Intended purpose of the device may include below information

a)     What is to be detected and/or measured

b)     Function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic

c)      Disease or specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate

d)     Whether it is automated or not

e)     Whether it is qualitative, semi-quantitative or quantitative

f)      Type of specimen(s) required

g)     Testing population

h)     Intended user

i)       Companion diagnostics: relevant target population and the associated medicinal product(s).

d)     Principles of the assay method or the principles of operation of the instrument

e)     Rationale for the qualification of the product as a device

f)      Risk class of the device and the justification for the classification rule(s) 

g)     Description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers

h)     Description specimen collection and transport materials provided with the device or descriptions of specifications recommended for use

i)       for instruments of automated assays: Description of the appropriate assay characteristics or dedicated assays;

j)      for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation;

k)     description of any software to be used with the device

l)       list of the various configurations/variants of the device that are intended to be made available on the market;

m)    accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device

1.2. Reference to previous and similar generations of the device

a)     Overview of previous generations of the device

b)      Overview of similar devices available in the EU or elsewhere

2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

        Complete set of labels

        Instructions for Use

3. DESIGN AND MANUFACTURING INFORMATION

3.1 Design Information

Information to allow key design stages to be understood

a)      critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device

b)     for instruments, a description of major subsystems, analytical technology such as operating principles and control mechanisms, dedicated computer hardware and software

c)      for instruments and software, an overview of the entire system

d)     for devices intended for self-testing or near-patient testing, a description of the design aspects that make them suitable for self-testing or near-patient testing

3.2 Manufacturing information

a)     information to allow the manufacturing processes

b)     identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed

4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

a)     Identification of applicable general safety and performance requirements and an explanation as to why others do not apply

b)     Methods used to demonstrate conformity

c)      Applicable standards, Common Specifications or other requirements

d)     Precise identity of the controlled documents offering evidence of conformity to demonstrating conformity with GSPRs. Cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT

a)     Benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and

b)     Solutions adopted and the results of the risk management referred to in Section 3 of Annex I.

6. PRODUCT VERIFICATION AND VALIDATION

6.1. Information on analytical performance of the device

6.1.1. Specimen type

Type of specimen and their stability including storage

 6.1.2. Analytical performance characteristics

6.1.2.1. Accuracy of measurement

a)     Trueness of measurement

b)     Precision of measurement

6.1.2.2. Analytical sensitivity

6.1.2.3. Analytical specificity

6.1.2.4. Metrological traceability of calibrator and control material values

6.1.2.5. Measuring range of the assay

6.1.2.6. Definition of assay cut-off

6.1.3. The analytical performance report referred to in Annex XIII.

 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report

 6.3. Stability (excluding specimen stability)

6.3.1. Claimed shelf-life

6.3.2. In-use stability

6.3.3. Shipping stability

 6.4. Software verification and validation

 6.5. Additional information required in specific cases

a)     Sterile devices or defined microbiological condition

b)     Devices containing Tissues or Cells of Human or Animal Origin or human or microbial orgin

c)      Measuring function device

d)     Device to be connected to other device(s) in order to operate

Annex III – Technical Documentation on Post Market Surveillance:

1.1.  The post-market surveillance plan drawn up in accordance with Article 79

1.2.   The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.


Click below link to know more about MDR Technical documentation:https://meddev-info.blogspot.com/2021/01/mdr-technical-documentation.html

Source:REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 

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