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 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 Clinical Evaluation.
In EU MDR 2017/745 Annex
XIV, Part A talks about Clinical Evaluation.
Let’s discuss in detail about Clinical Evaluation.
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CLINICAL EVALUATION
1. To plan, continuously
conduct and document a clinical evaluation, manufacturers shall:
(a) establish and update
a clinical evaluation plan, which shall include at least the following details
An identification of the
general safety and performance requirements that require support from relevant
clinical data.
A specification of the
intended purpose of the device.
A clear specification of
intended target groups with clear indications and contra-indications.
A detailed description of
intended clinical benefits to patients with relevant and specified clinical
outcome parameters.
A specification of
methods to be used for examination of qualitative and quantitative aspects of
clinical safety with clear reference to the determination of residual risks and
side-effects.
An indicative list and
specification of parameters to be used to determine, based on the state of the
art in medicine, the acceptability of the benefit-risk ratio for the various
indications and for the intended purpose or purposes of the device.
An indication how
benefit-risk issues relating to specific components such as use of
pharmaceutical, nonviable animal or human tissues, are to be addressed.
A clinical development
plan indicating progression from exploratory investigations, such as first-in-man
studies, feasibility and pilot studies, to confirmatory investigations, such as
pivotal clinical investigations, and a PMCF as referred to in Part B of this
Annex with an indication of milestones and a description of potential
acceptance criteria.
(b) identify available
clinical data relevant to the device and its intended purpose and any gaps in
clinical evidence through a systematic scientific literature review.
(c) appraise all relevant
clinical data by evaluating their suitability for establishing the safety and
performance of the device.
(d) generate, through
properly designed clinical investigations in accordance with the clinical
development plan, any new or additional clinical data necessary to address
outstanding issues.
(e) analyse all relevant
clinical data in order to reach conclusions about the safety and clinical
performance of the device including its clinical benefits.
2. The clinical
evaluation shall be thorough and objective, and take into account both
favorable and unfavourable data. Its depth and extent shall be proportionate
and appropriate to the nature, classification, intended purpose and risks of
the device in question, as well as to the manufacturer's claims in respect of
the device.
3. A clinical evaluation
may be based on clinical data relating to a device for which equivalence to the
device in question can be demonstrated. The following technical, biological and
clinical characteristics shall be taken into consideration for the
demonstration of equivalence:
Technical: the device is
of similar design; is used under similar conditions of use; has similar
specifications and properties including physicochemical properties such as
intensity of energy, tensile strength, viscosity, surface characteristics,
wavelength and software algorithms; uses similar deployment methods, where
relevant; has similar principles of operation and critical performance
requirements.
Biological: the device
uses the same materials or substances in contact with the same human tissues or
body fluids for a similar kind and duration of contact and similar release
characteristics of substances, including degradation products and leachables.
Clinical: the device is
used for the same clinical condition or purpose, including similar severity and
stage of disease, at the same site in the body, in a similar population,
including as regards age, anatomy and physiology; has the same kind of user;
has similar relevant critical performance in view of the expected clinical
effect for a specific intended purpose.
Considerations of
equivalence shall be based on proper scientific justification. It shall be
clearly demonstrated that manufacturers have sufficient levels of access to the
data relating to devices with which they are claiming equivalence in order to
justify their claims of equivalence.
4. The results of the
clinical evaluation and the clinical evidence on which it is based shall be
documented in a clinical evaluation report which shall support the assessment
of the conformity of the device. The clinical evidence together with
non-clinical data generated from non-clinical testing methods and other
relevant documentation shall allow the manufacturer to demonstrate conformity
with the general safety and performance requirements and shall be part of the
technical documentation for the device in question. Both favourable and
unfavourable data considered in the clinical evaluation shall be included in
the technical documentation.
Now I hope you have acquired some knowledge about EU MDR 2017/745 Clinical Evaluation. 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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