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Templates Clinical Evaluation Templates

Updated October 24, 2022

Template: Clinical Evaluation Plan

Dr. Oliver Eidel

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

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Clinical Evaluation Plan

The Clinical Evaluation Plan defines methods for creating and updating the Clinical Evaluation Report. This plan is updated later by the post-market clinical follow-up, e.g., to include new search criteria for the literature search.

While the content of the Clinical Evaluation is simple, writing it, coming up with the right structure and forming a sensible line of reasoning (equivalence) can be a bit tricky.

These are the guidance documents on Clinical Evaluation. If you’re the person writing it, you should read them:


Table of Contents

A list of the sections is presented below. You have to update this manually when you edit headings as this is a markdown file (sorry - guilty dog face).

Relevant Documents

  1. Scope of the Clinical Evaluation
  2. Device
    2.1. Device Description
    Intended Use
    User Profile
    Precautions/Safety Instructions
    Use Environment
    Operating Principle
    Design Requirements
    2.2. Clinical Benefits, Outcome Parameters
    2.3. Clinical Safety, Methods for Analysis
    2.4. Acceptability of Benefit-Risk-Ratio
  3. Type of Evaluation
  4. Literature Search
    4.1. Literature Search Methods
    4.2. Literature Appraisal Criteria
    4.3. Additional Databases
  5. References

Relevant Documents



Describe the roles of people who will be doing the Clinical Evaluation.

Role Name
Review / Approval  

1. Scope of the Clinical Evaluation

Note: This section will be copy-pasted into the Clinical Evaluation Report

Based on MEDDEV 2.7/1 rev. 4, the Clinical Evaluation is performed in five logical procedural stages in order to evaluate the performance and safety data of the medical device:


2.1 Device Description

Copy-paste your Device Description here, which includes the Intended Use but also, User Profile, Precautions/Safety Instructions, Contraindications, Use Environment, Operating Principle, Variants/Accessories, Novelty, Design Requirements. If it’s not done yet, remember to do it later :)

2.2 Clinical Benefits, Outcome Parameters

Describe the clinical benefits you expect from your product. Define how you’ll measure those (i.e., outcome parameters). You’ll probably be planning to do a literature search to prove them. As you know the literature, it makes sense to select outcome parameters which were already established in prior studies. For example, if your website claims that your device cures back pain in 50% of patients after 14 days, here’s the place to list that claim and show and explain how you’ll prove it.

Also, describe the product claims as stated by MEDDEV 2.7/1 Rev. 4: Medical device claims results from general requirements on safety and performance. These claims are part of materials (e.g. IFU, marketing material and other accompanying documents). These product claims will be checked within the clinical evaluation and evidence are made. Performance-related product claims:

2.3 Clinical Safety, Methods for Analysis

Describe your safety parameters, i.e., which things should your product fulfil so that you consider it safe? And your methods, i.e., how will you prove that your product fulfils those safety parameters? A method could be a literature search for past studies, but you could additionally do a Post-Market Clinical Follow-Up to double-check whether that’s actually true for your device.

For MD class I: does it replace the medical care chain? Is the case that only a doctor can diagnose causes or concomitant diseases in the case of occurring complaints and prescribe necessary therapies if needed? Are there any side effects expected? If however any side effects occur during the use, can the patient interrupt the process any time?

Also, make sure to mention that a risk management plan, risk assessment and risk management report were undertaken according to the EN ISO 14971:2019 to evaluate all the known and foreseeable risks related to the product.

Safety-related product claims:

2.4 Acceptability of Benefit-Risk Ratio

After you’ve defined your benefits and safety parameters, which combination of those is acceptable to you? In the case of most software devices (and apps), you’ll probably have subtle benefits (e.g., better disease management, early detection of relapses) while low safety concerns (e.g., disease progression unlikely, not killing anyone).

3. Type of Evaluation

Describe the type of Clinical Evaluation you’ll be doing. Most probably, you’ll be doing a literature search to come up with adequate clinical data.

4.1 Literature Search Methods

Describe your literature search methods, the databases you’ll be using (PubMed, Google Scholar, Cochrane, Embase), the keywords you’ll be entering and how you plan to document it (you’ll be creating a table, I suppose).

Comment if systematic search and review methods such as the following have been used:

I blindly copy-pasted some semi-helpful bullet points from guidance documents here:

It makes sense to differentiate between “context” and “pivotal” data:

4.2 Literature Appraisal Criteria

Describe your criteria for clinical data which you deem acceptable for your clinical evaluation. Firstly, the information should be relevant. Secondly, you’ll probably have some additional hard criteria, like requirements for the study design etc.

Also, how will you weigh the information from multiple studies?

You can evaluate the appraisal of pivotal data by considering the equivalence of the described device literature (e.g., material & methods part, algorithm, models); the level of evidence can be taken from different sources (LoE of American Heart Association or quality of clinical data according to MDCG Guideline 2020-6).

4.3 Additional Databases (if applicable)

You can also check out additional databases for relevant data and mention how you search them:

5. References (if applicable)

Papers and other references which you cite can go here.

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