European manufacturer
need to address the General safety and performance requirements(GSPRs) to
comply MDR 2017/745. Technical documentation is created to address the
GSPRs.
MDR Annex II & III
provides the technical documentation structure.
European manufacturer need to address the General safety and performance requirements(GSPRs) to comply MDR 2017/745.
MDR 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 patient population and medical conditions to
be diagnosed, treated and/or monitored and other considerations such as patient
selection criteria, indications, contra-indications, warnings;
d) Principles of operation and mode of action
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)
Novel features
h) Description of the accessories and combination
i) Description or complete list of the various
configurations/variants
j) Description of the key functional elements
k) description of the raw materials incorporated into key
functional elements
l)
Technical and material specification,
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
a) Information to allow key design stages to be understood
b) manufacturing processes and their validation, their
adjuvants, the continuous monitoring and the final product testing
c) Identification of all suppliers and subcontractors undertaking design or manufacturing processes for the
manufacturer
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.
Pre-clinical and clinical data
a)
Results of tests, such as
engineering, laboratory, simulated use and animal tests, and evaluation of
published literature applicable to the device
b)
Information regarding test design,
complete test or study protocols, methods of data analysis, in addition to data
summaries and test conclusions regarding in particular:
—Biocompatibility
— Physical,
chemical and microbiological characterisation
— Electrical
safety and electromagnetic compatibility;
— Software
verification and validation
— Stability,
including shelf life
— Performance
and safety
c)
Clinical evaluation plan& report
d) PMCF
plan and PMCF evaluation report or a justification why a PMCF is not applicable
6.2. Additional information required in specific cases
a) Devices containing Medicinal
Products
b) Devices containing Tissues or Cells
of Human or Animal Origin or their Derivatives
c) Devices containing Substances or
Combinations of Substances that are Intended to be Introduced into the Human
Body and that are absorbed by or Locally Dispersed in the Human Body:
d) Devices containing CMR or endocrine-disrupting
substances
e) Sterile devices
f)
Measuring function device
g) 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 84.
1.2.
The PSUR
referred to in Article 86 and the post-market surveillance report referred to
in Article 85.
Click below link to know more about IVDR Technical documentation:https://meddev-info.blogspot.com/2021/03/ivdr-technical-documentation.html
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