Appraisal Plan
For
[Device Name]
Approval
Author Approval
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Approval
|
|
Name:
|
Date:
|
|
Title:
|
Signature:
|
Evaluator Approval
|
Approval
|
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Name:
|
Date:
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Title:
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Signature:
|
|
Approval
|
|
Name:
|
Date:
|
|
Title:
|
Signature:
|
Revision History
Table 1: History of revision
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Revision
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Date
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Change History
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Ranking from MDCG 2020-6 (April 2020)
Table 1: MDCG 2020-6 rank
|
Rank
|
Types of clinical data and evidence
|
|
1
|
Results of high-quality clinical investigations covering all device variants, indications, patient populations, duration of treatment effect, etc
|
|
2
|
Results of high-quality clinical investigations with some gaps
|
|
3
|
Outcomes from high-quality clinical data collection systems such as registries
|
|
4
|
Outcomes from studies with potential methodological flaws but where data can still be quantified, and acceptability justified
|
|
5
|
Equivalence data (reliable / quantifiable)
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|
6
|
Evaluation of state of the art, including evaluation of clinical data from similar devices
|
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7
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Complaints and vigilance data; curated data
|
|
8
|
Proactive PMS data, such as that derived from surveys
|
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9
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Individual case reports on the subject device
|
|
10
|
Compliance to non-clinical elements of common specifications considered relevant to device safety and performance
|
|
11
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Simulated use / animal / cadaveric testing involving healthcare professionals or other end users
|
|
12
|
Pre-clinical and bench testing / compliance to standards
|
Suitability
Table 2: Criteria of suitability
|
Suitability criteria
|
Description
|
Grading System
|
|
Appropriate device
|
Were the data generated from the device in question?
|
D1
|
Subject device
|
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D2
|
Equivalent device / similar devices
|
|
D3
|
Similar device / alternative treatments
|
|
Appropriate device application
|
Was the device used for the same intended use (e.g., methods of deployment, application, etc.)?
|
A1
|
Same use
|
|
A2
|
Off-label use
|
|
A3
|
Unspecified use
|
|
Appropriate patient group
|
Were the data generated from a patient group that is representative of the intended treatment population (e.g., age, sex, etc.) and clinical condition (i.e., disease, including state and severity)?
|
P1
|
Targeted population
|
|
P2
|
Contraindicated population
|
|
P3
|
Other population
|
|
Acceptable report/data collation
|
Do the reports or collations of data contain sufficient information to be able to undertake a rational and objective assessment?
|
R1
|
Key safety and performance measures
|
|
R2
|
Other safety and performance measures
|
|
R3
|
No safety and performance measure
|
Contribution
Table 3: Criteria of contribution
|
Data contribution criteria
|
Description
|
Grading System
|
|
Data source type
|
Was the design of the study appropriate?
|
T1
|
Yes
|
|
T2
|
No
|
|
Outcome measures
|
Do the outcome measures reported reflect the intended performance of the medical device?
|
O1
|
Yes
|
|
O2
|
No
|
|
Follow up
|
Is the duration of follow-up long enough to assess whether duration of treatment effects and identify complications?
|
F1
|
Yes
|
|
F2
|
No
|
|
Statistical significance
|
Has a statistical analysis of the data been provided and is it appropriate?
|
S1
|
Yes
|
|
S2
|
No
|
|
Clinical significance
|
Was the magnitude of the treatment effect observed clinically significant?
|
C1
|
Yes
|
|
C2
|
No
|
Oxford Level of evidence (LoE)
Table 4: Level of clinical evidence for therapy or prevention of disease
|
LoE
|
Description
|
|
1
|
Systematic reviews of randomized controlled trials
Individual randomized controlled trials
|
|
2
|
Systematic reviews of cohort studies
Individual cohort study
low quality randomized controlled trials
|
|
3
|
Systematic review of case-control studies
individual case-control study
|
|
4
|
Case series
|
|
5
|
Expert opinion
|
Article Quality
Table 4: Criteria of article quality
|
Quality level
|
Criteria
|
|
High quality
|
Rank 1, 2, 3, 4 or 5; LoE 1 or 2; D1 or D2; A1; P1; S1.
|
|
Low quality
|
Rank 1, 2, 3, 4 or 5; LoE 1 or 2 or 3; D1 or D2; A1; P1; S1 or S2.
|
|
Off label
|
Rank 1, 2, 3, 4 or 5; LoE 1 or 2 or 3 or 4, D1 or D2; A1 or A2; P1 or P2 or P3; S1 or S2
|
Application of appraisal methods
Table 5: Application of appraisal criteria by type of clinical data
|
Appraisal criteria
Type of clinical data
|
MDCG 2020-6
|
Suitability
|
Contribution
|
Quality
|
LoE
|
|
Clinical/PMCF investigation / PMCF registry
|
Yes
|
Yes
|
Yes
|
–
|
Yes
|
|
PMCF survey
|
Yes
|
–
|
–
|
–
|
–
|
|
Literature article for the subject device / equivalent device
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
|
Literature article for SoA
|
Yes
|
–
|
–
|
–
|
–
|
|
Literature article for AC
|
Yes
|
Yes
|
Yes
|
–
|
Yes
|
|
PMS data hold by the manufacturer for subject device / equivalent device
|
Yes
|
–
|
–
|
–
|
–
|
|
External vigilance/recall data
|
Yes
|
–
|
–
|
–
|
–
|
|
Preclinical data
|
Yes
|
–
|
–
|
–
|
–
|
