Hi friends!!!
In our previous blog, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation - Part 1
EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.
Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Technical Documentation.
Let’s discuss in detail about Technical Documentation.
TECHNICAL DOCUMENTATION
In EU MDR 2017/745, the Annex II explains about Technical Documentation. The Technical Documentation structure in EU MDR 2017/745 has following six sections.
1. Device description and specification, including variants and accessories
2. Information to be supplied by the manufacturer.
3. Design and Manufacturing information.
4. General safety and performance requirements.
5. Benefit-risk analysis and risk management.
6. Product verification and validation.
We have discussed about the sections one, two & three in our previous blog EU MDR Technical Documentation - Part 1.
Let’s discuss in detail about remaining sections.
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4. GENERAL SAFETY AND PERFORMANCE
REQUIREMENTS
The documentation shall
contain information for the demonstration of conformity with the general safety
and performance requirements set out in Annex I that are applicable to the
device taking into account its intended purpose, and shall include a justification,
validation and verification of the solutions adopted to meet those
requirements. The demonstration of conformity shall include:
a. The general safety and
performance requirements that apply to the device and an explanation as to why
others do not apply.
b. The method or methods
used to demonstrate conformity with each applicable general safety and
performance requirement.
c. The harmonised
standards, CS or other solutions applied.
d. The precise identity
of the controlled documents offering evidence of conformity with each
harmonised standard, CS or other method applied to demonstrate conformity with
the general safety and performance requirements. The information referred to
under this point shall incorporate a 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
The documentation shall
contain information on the following:
a. The benefit-risk
analysis referred to in Sections 1 and 8 of Annex I.
b. The solutions adopted
and the results of the risk management referred to in Section 3 of Annex I.
6. PRODUCT VERIFICATION AND
VALIDATION
The documentation shall
contain the results and critical analyses of all verifications and validation
tests and/or studies undertaken to demonstrate conformity of the device with
the requirements of this Regulation and in particular the applicable general
safety and performance requirements.
6.1. PRE-CLINICAL AND CLINICAL DATA
The results of tests,
such as engineering, laboratory, simulated use and animal tests, and evaluation
of published literature applicable to the device, taking into account its
intended purpose, or to similar devices, regarding the pre-clinical safety of
the device and its conformity with the specifications.
a. Detailed information
regarding test design, complete test or study protocols, methods of data
analysis, in addition to data summaries and test conclusions regarding in
particular:
b. The biocompatibility
of the device including the identification of all materials in direct or
indirect contact with the patient or user.
Physical, chemical and
microbiological characterization.
Electrical safety and
electromagnetic compatibility.
Software verification and
validation (describing the software design and development process and evidence
of the validation of the software, as used in the finished device. This
information shall typically include the summary results of all verification,
validation and testing performed both in-house and in a simulated or actual
user environment prior to final release. It shall also address all of the
different hardware configurations and, where applicable, operating systems
identified in the information supplied by the manufacturer).
Stability, including
shelf life.
Performance and safety.
Where applicable,
conformity with the provisions of Directive 2004/10/EC of the European
Parliament and of the Council ( 1 ) shall be demonstrated.
Where no new testing has
been undertaken, the documentation shall incorporate a rationale for that
decision. An example of such a rationale would be that biocompatibility testing
on identical materials was conducted when those materials were incorporated in
a previous version of the device that has been legally placed on the market or
put into service.
c. The clinical
evaluation report and its updates and the clinical evaluation plan referred to
in Article 61(12) and Part A of Annex XIV.
d. The PMCF plan and PMCF
evaluation report referred to in Part B of Annex XIV or a justification why a
PMCF is not applicable.
Now I hope you have acquired some knowledge about EU MDR 2017/745 Technical Documentation. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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