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
