Appraisal plan

Clinical evaluation template

Appraisal Plan template for medical device clinical evaluation

Use this editable Appraisal Plan to define how clinical evidence will be ranked, assessed and weighted before it feeds your Clinical Evaluation Report, PMCF activities, PMS review or safety and performance conclusions.

Structure the appraisal methodSet objective rules before reviewers assess clinical evidence.

Align with MDCG 2020-6Rank clinical data sources and document why stronger evidence carries more weight.

Support audit-ready decisionsMake suitability, contribution and article quality decisions easier to trace.

Best for: clinical evaluation planning, literature appraisal, PMCF evidence review and CER preparation.
Includes: MDCG 2020-6 ranking, D/A/P/R suitability grading, T/O/F/S/C contribution grading and Oxford Level of Evidence classification.
Format: editable template available through the standard WooCommerce download flow.

Need the editable file?
Add the free template to cart

At Lexqara, we connect clinical documentation, PMS activities and regulatory strategy so manufacturers can justify clinical evidence decisions with a clear and repeatable appraisal method. Explore the Resource Center, review our Clinical Evaluation Services, or consult MDCG 2020-6 for the clinical evidence hierarchy referenced in this template.

Template preview

Template preview: appraisal method and evidence-ranking tables

Review the key sections included in the Appraisal Plan template before downloading it. The preview shows how the document structures clinical evidence ranking, suitability assessment, contribution assessment and Oxford Level of Evidence classification for medical device clinical evaluation.

MDCG 2020-6 rankingPrioritise clinical evidence by strength and relevance.

Suitability scoringAssess device, application, patient group and reporting fit.

Contribution scoringWeight outcomes, follow-up, study type and clinical significance.

Open the HTML preview

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)
6	Evaluation of state of the art, including evaluation of clinical data from similar devices
7	Complaints and vigilance data; curated data
8	Proactive PMS data, such as that derived from surveys
9	Individual case reports on the subject device
10	Compliance to non-clinical elements of common specifications considered relevant to device safety and performance
11	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^[1]

Suitability criteria	Description	Grading System
Appropriate device	Were the data generated from the device in question?	D1	Subject device
		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^[2]

Data contribution criteria	Description	Grading System
Data source type	Was the design of the study appropriate?	T1	Yes
Data source type	Was the design of the study appropriate?	T2	No
Outcome measures	Do the outcome measures reported reflect the intended performance of the medical device?	O1	Yes
Outcome measures		O2	No
Follow up	Is the duration of follow-up long enough to assess whether duration of treatment effects and identify complications?	F1	Yes
Follow up		F2	No
Statistical significance	Has a statistical analysis of the data been provided and is it appropriate?	S1	Yes
Statistical significance		S2	No
Clinical significance	Was the magnitude of the treatment effect observed clinically significant?	C1	Yes
Clinical significance		C2	No

Oxford Level of evidence (LoE)

Table 4: Level of clinical evidence^[3] 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

The full editable template is available after adding the product to cart.

Download the editable template

Free

SKU LEX-FORM-EU-010 rev.1 Category Clinical Documents