Det Norske Veritas Certification AS, Norway
Clinical evaluation checklist for Notified Bodies
Ref
Requirement
Fulfilled
Comment
0
Conformity without Clinical Data
0.1
Any demonstration of conformity without clinical data
(Annex 7.1.5 of 90/385/EEC and Annex X.1.1d of
93/42/EEC) must be adequately justified and based on
· the output of the risk management process
· viewed in the context of the device-body interaction
· the intended clinical performance
· the claims of the manufacturer.
Adequacy of demonstration of conformity based on
performance evaluation, bench testing and pre-clinical
evaluation in the absence of clinical evaluation must be
duly substantiated.
The notified body must review the manufacturer’s
justification, the adequacy of data presented and whether
or not conformity is demonstrated.
· Is the manufacturer’s justification adequate?
· Is the performance evaluation, bench testing and preclinical
evaluation adequate to demonstrate
conformity to the Essential Requirements?
Yes
No
N/A
1
Clinical Evaluation, General
1.1
The manufacturer should include in the technical
documentation a statement on the route(s) applied to
retrieve the clinical data used to affix the “CE”
marking.
The statement should make clear whether that
clinical data was obtained from the published
literature or the results of clinical investigations or a combination of both and shall include an adequate
justification of the route(s) selected and a
demonstration of equivalency (technical, biological,
clinical) and adequacy if clinical data from similar devices have been used.
Yes
No
N/A
Clinical literature
Published
Unpublished
Equivalence demonstrated
Clinical investigation
Combination of literature and investigation data
Comment
1.2
The Clinical Evaluation Report and the full clinical
data used for CE marking should be included within
the technical documentation
Yes
No
N/A
1.3
The manufacturer has clearly documented the
objectives and the scope of the clinical evaluation
and specified the clinical ER’s [e.g. clinical
performance(s), safety, risks and favourable
benefit/risk ratio related to intended use, target
group(s) and indication(s)] to be met
Yes
No
N/A
1.4
The manufacturer has clearly outlined the performed
steps and procedures of clinical evaluation according
to this MEDDEV (specifically sections 5 to 9),
adequate justification given for deviations
Yes
No
N/A
2
Clinical investigation route
Not applicable
3
Clinical literature data
A critical evaluation of relevant scientific literature that is currently available relating to safety, performance, design characteristics and intended purpose in the form of a written report
3.1
Methodology
3.1.1
A critical evaluation of relevant scientific literature has
been presented
Yes
No
N/A
3.1.2
A search protocol for the identification, selection,
collation and review of relevant publications should be written
Yes
No
N/A
3.1.3
The objective of the literature review should be clearly
defined
Yes
No
N/A
3.1.4
The types of studies that are relevant to the objective of
the literature review should be specified
Yes
No
N/A
3.1.5
Data should be taken from recognised scientific
publications. Unpublished data should also be taken into
account in order to avoid publication bias.
Yes
No
N/A
3.1.6
The literature review should state:
3.1.6.1
sources of data, extent of the searches of databases or
other sources of information
Yes
No
N/A
3.1.6.2
rationale for the selection/ relevance of the published
literature
Yes
No
N/A
3.1.6.3
reasons for believing that all relevant references, both
favorable and unfavorable, have been identified
Yes
No
N/A
3.1.6.4
criteria for exclusion of particular references together
with a justification for this exclusion.
Yes
No
N/A
3.1.6.5
detailed description of the different stages of
literature search (including identification, appraisal,
analysis and conclusion of hits)
Yes
No
N/A
3.2
Relevance of data presented
3.2.1
A literature review should clearly establish the extent
to which the literature relates to the specific
characteristics and features of the device under
consideration.
Yes
No
N/A
3.2.2
If the published studies do not directly refer to the
device in question, the manufacturer must demonstrate equivalence with the device, which is the subject of the published reports.
Yes
No
N/A
3.2.3
To be equivalent, the devices should have similarity
with regard to the clinical, technical and biological
parameters with special attention to the performance,
principles of operation and materials; or if there are
differences identified, an assessment and
demonstration of the significance these might have
on safety and performance must be set out
Yes
No
N/A
3.2.4
The manufacturer must be able to demonstrate the
adequacy of the data in addressing the aspects of
conformity set out in the objective
Yes
No
N/A
3.3
NB Assessment of clinical data
The literature review should make clear the significance that is attached to particular references based on a number of factors. These include:
3.3.1
relevance of the author’s background and expertise in
relation to the particular device and/or medical procedure
involved
Yes
No
N/A
3.3.2
whether the author’s conclusions are substantiated by the
available data
Yes
No
N/A
3.3.3
whether the literature reflects the current medical practice
and the generally acknowledged “state of the art“
technologies
Yes
No
N/A
3.3.4
whether references are taken from recognised scientific
publications and whether or not they have been reported in peer reviewed journals
Yes
No
N/A
3.3.5
the extent to which the published literature is the outcome
of a study/studies which have followed scientific
principles in relation to design
Yes
No
N/A
3.4
Critical evaluation of the literature
The literature review should contain a critical evaluation of the literature. This critical evaluation should:
3.4.1
be written by a person suitably qualified in the relevant
field, and reviewed and approved by an expert
knowledgeable in the “state of the art” and able to
demonstrate objectivity
Yes
No
N/A
3.4.2
contain a short description of the medical device, its
intended functions, description of the intended purpose
and application of use
Yes
No
N/A
3.4.3
contain an analysis of all the available data considered,
both favourable and unfavourable
Yes
No
N/A
3.4.4
establish the extent to which the literature relates to the
specific characteristics and features of the device being
assessed, taking due account of the extend of similarity
between the device(s) covered by the literature and the
device under assessment
Yes
No
N/A
3.4.5
demonstrate that those aspects of the use of the device,
including performance, addressed in the clinical part of
the risk analysis are met as claimed by the manufacturer,
and that the device fulfils its intended purpose as a medical device
Yes
No
N/A
3.4.6
analyse the identified hazards, the associated risks and the
appropriate safety measures of patients, medical staff and
Yes
No
N/A
3.4.7
contain a risk analysis relevant to the device design,
materials and procedures involved, taking into account
any adverse events, results of post-market surveillance
studies, modifications and recalls (if known)
Yes
No
N/A
3.4.8
contain a description of the methods of weighting of
different papers and the statistical methods of analysis
employed taking into account the assessment methods, the
type and duration of study and the heterogeneity of the
population included within the study
Yes
No
N/A
3.4.9
include an analysis of the market experience of the same
or similar devices, including the results of post-marketing
studies, post-market surveillance and short- and long-term
adverse events
Yes
No
N/A
3.4.10
contain a list of publications appropriately crossreferenced
in the evaluation
Yes
No
N/A
3.4.11
if the clinical data relates to an equivalent device, contain
a statement that equivalence with all the relevant
characteristics has been demonstrated
Yes
No
N/A
3.4.12
include a conclusion
with a justification, including an
assessment of any probable benefit to health from the use
of the device as intended by the manufacturer, against
probable risks of injury or illness from such use taking
account of the “state of the art”. The conclusions should
make clear how the objectives of the literature review
have been met and identify any gaps in the evidence
necessary to cover all relevant aspects of safety and
performance
Yes
No
N/A
3.4.13
The critical evaluation should be signed and dated by the
author
Yes
No
N/A
3.5
NB Assessment of the critical evaluation of literature
presented by the manufacturer
3.5.1
Are the manufacturers’ conclusions valid?
Yes
No
N/A
3.5.2
Is the data, taken together with the available pre clinical
data, sufficient to demonstrate compliance with the
essential requirements covering safety and performance of
the device in question under normal conditions of use?
Yes
No
N/A
3.5.3
Are the claims made in the device labeling substantiated
by the clinical data taken together with the pre-clinical
data?
Yes
No
N/A
3.5.4
Was the assessment performed in a critical and objective
manner?
Yes
No
N/A
4
Post-market clinical follow up – the notified body
should check and review the manufacturer’s post
market clinical follow up plan:
4.1
Has the manufacturer presented an appropriate plan for
post-market clinical follow up in line with appropriate
guidance?
Yes
No
N/A
4.2
If no post-market clinical follow up plan is presented, has
this been adequately justified by the manufacturer?
Yes
No
N/A
4.3
Has the manufacturer an adequate post-market
surveillance system in place?
Yes
No
N/A
4.4
Has the manufacturer committed to inform the NB of
significant updates to their clinical evaluation arising from PMS/PMCF?
Yes
No
N/A
5
Notified Body Decision Making
5.1
In reviewing the evaluation of clinical data submitted by the manufacturer the NB must decide whether the manufacturer has adequately
5.1.1
described and verified the intended characteristics and
performances related to clinical aspects
Yes
No
N/A
5.1.2
performed a risk analysis and estimated the undesirable
side effects
Yes
No
N/A
5.1.3
concluded on the basis of documented justification that
the risks are acceptable when weighed against the
intended benefits
Yes
No
N/A
5.2
NB assessment of benefit/risk presented in the clinical
evaluation data
5.2.1
the listing and characterisation of the clinical performance
of the device intended by the manufacturer and the
expected benefits for the patient
Yes
No
N/A
5.2.2
the use of the list of identified hazards to be addressed
through evaluation of clinical data
Yes
No
N/A
5.2.3
the adequate estimation of the associated risks for each
identified hazard by:
a) characterising the severity of the hazard;
b) estimating and characterising the probability of
occurrence of the harm (or health impairment or loss of
benefit of the treatment) (document with rationale)
Yes
No
N/A
5.2.4
the decision on the acceptability of risks in relation to
each identified hazard
Yes
No
N/A
� Equivalence means:
Clinical: used for the same clinical condition or purpose, at the same site in the body, in similar population (including age, anatomy, physiology); have similar relevant
critical performance according to expected clinical effect for specific intended use.
Technical: used under similar conditions of use; have similar specifications and properties e.g. tensile strength, viscosity, surface characteristics; be of similar design; use
similar deployment methods (if relevant); have similar principles of operation.
Biological: use same materials in contact with the same human tissues or body fluids.
� For example in having demonstrable and appropriate endpoints, inclusion and exclusion criteria, an appropriate and validated number of patients submitted, carried out for an appropriate duration, providing evidence and analysis of all adverse incidents, deaths, exclusions, withdrawals and subjects lost follow-up and identifying an appropriate statistical plan of analysis. Ideally, evidence should be generated from a clinical trial (controlled if appropriate), properly designed cohort/case controlled study, well documented case histories or sequential reports conducted by appropriate experienced experts, whether in relation to the device itself or an equivalent device. If unpublished data is being included in the assessment, the literature review will need to weigh the significance that is attached to each report.
� Conclusions should consider the claimed use - indications, contra-indications and instructions for use proposed by the manufacturer.
� If not, identify gaps in the demonstration of compliance with the relevant essential requirements or in the demonstration of equivalence that need addressing through the means of a specifically designed clinical investigation(s).
1
ICP-4-5-i3-MDD-f8
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