Clinical Evaluation Report#

The Clinical Evaluation Report states the clinical benefits and safety characteristics of the device, based on clinical data. It is the output of the Clinical Evaluation Plan.

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:

  • MDCG 2020-1, 2020-5, 2020-6

  • MDCG 2020-13: Quite helpful as it gives you an idea of the structure.

  • MEDDEV 2.7.1 rev. 4. (mostly for MDD, but still a good starting point; especially the list of proposed headings for a report at the end of the document).

Finally, this Clinical Evaluation Report is for Medical Devices. If you are an IVD manufacturer you will write a Performance Evaluation Report which has many similarities but some essential parts are different, e.g., Post-Market Performance Follow-Up and procedural descriptions of evaluation and validation).


  • Name: <product name>

  • Version: <product version>

  • Basic UDI-DI: <insert UDI-DI, if/when available>

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).

  1. List of Abbreviations

  2. Product

  3. Relevant Documents

  4. Scope of the Clinical Evaluation

  5. Device

  6. Clinical Background, Current Knowledge, State of the Art

  7. Type of Evaluation

  8. Equivalence

  9. Literature Search

  10. Clinical Data

  11. Post-Market Activities

  12. Conclusions

  13. Date of the Next Clinical Evaluation

  14. Dates and Signatures

  15. Qualification of the Responsible Evaluators

  16. References

1. List of Abbreviations#




Adverse Event


German Federal Institute for Drugs and Medical Devices


Communauté Européenne


Clinical Evaluation Report


Confidence interval


Design History File


Device Master Record


European Database for MEdical Devices


Food and Drug Administration (US)


Instruction for Use


Level of Evidence


Manufacturer and User Facility Device Experience


Guideline for Clinical Evaluation of Medical Devices


Medical Device Directive, European Directive 93/42/EEC


Medical Device Directive, 2017/745


Post Market Surveillance


Post MArket clinical Follow Up




Standard Operation Procedure






World Health Organization

2. Product#

  • Name: <product name>

  • Version: <product version>

  • Basic UDI-DI: <insert UDI-DI, if/when available>

  • UMDNS-Code:

  • GMDN-Code:

The classification is based on the following criteria:

Select one of these two, based on whether you’re going for MDD or MDR compliance.

  • Annex IX of the European Directive 93/42/EEC (MDD): <if applicable>

  • According to the EU Regulation 2017/745 (MDR) Annex VIII Rules: <if applicable>.

3. Relevant Regulatory References#

Other relevant regulatory documents:

  • SOP Clinical Evaluation

  • Clinical Evaluation Plan

  • Instructions for Use (IFU)

This clinical evaluation report serves as evidence of conformance with certain General Safety and Performance Requirements pursuant to EU Regulation 2017/745 (MDR), Annex I.

Specifically, the following requirements were evaluated as part of this report:

  • Chapter 1 (General Requirements), para. 1 and 8

  • Chapter 2.8 (Software Devices), para. 17.2

4. Scope of the Clinical Evaluation#

Note: This section is copy-pasted from the Clinical Evaluation Plan.

The following section can be part of the Clinical Evaluation Plan or pasted here with reference to the respective chapters. Remember that you can update the Clinical Evaluation Plan during your evaluation (e.g., your search criteria are not sufficient).

The approach according to the MEDDEV 2.7/1 rev. 4 includes five logical procedural stages in order to evaluate the performance and safety data of the medical device:

  • Step 0 (“Scope”)

  • Step 1 (“Identification”)

  • Step 2 (“Appraisal”)

  • Step 3 (“Analysis”)

  • Step 4 (“Report”)

During the working process, these five steps are iterative and influence each other. The report shows the steps in a sequential way. In the present report (step 4), the steps 0 through 3 are corresponding to the following chapters:

List sections of the Clinical Evaluation Report here which cover the steps above.

5. Device#

5.1 Device Description#

Copy-paste your Device Description (which includes the Intended Use) here. If it’s not done yet, remember to do it later :)

Also, reference your Essential Requirements Document here.

5.2 Clinical Benefits, Outcome Parameters#

Medical device claims are statements from accompanying documents, marketing material, your website, etc. that include information about the performance and safety of the medical device (information by the manufacturer). The clinical evaluation is done in order to determine whether those claims are confirmed by sufficient clinical evidence.

So, 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 explain how you’ll prove it.

Claims that have not been stated so far (e.g., in the IFU) are described below and sorted according to their meaning for performance and safety. In this clinical evaluation, it was determined that the claims are sufficiently supported by clinical data.

Performance-related product claims:

  • Claim 1

  • Claim 2

5.3 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.

Safety-related product claims:

  • Claim 1

  • Claim 2

5.4 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).

6. Clinical Background, Current Knowledge, State of the Art#

This chapter focus on literature and guidelines that describe the current state of the art and other topics. It is similar to the literature / introduction chapter of papers.

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

  • Context data describes the state of the art (commonly the introduction / literature part of papers)

  • Pivotal data is used for the appraisal, i.e., that’s the data describing the actual study and outcome(s). In the best case, the pivotal data is about the actual device you’re claiming equivalence to.

6.1 Clinical Background & Current Knowledge#

Describe the clinical context of the disease you’re treating: How are patients currently treated? Which symptoms do they have, which diagnostic modalities are being used to establish a diagnosis, which treatment options exist? What are the benefits and drawbacks of current treatment options?

6.2 State of the Art incl. Alternative Treatments#

Given the current treatment options, what is the preferred, “state of the art” treatment? What are its benefits and drawbacks? Are there recent scientific achievements (studies, new technologies, software) which may be promising to improve this state-of-the-art treatment? Also, what are alternative treatments?

7. Type of Evaluation#

Note: This section is copy-pasted from the Clinical Evaluation Plan.

9. Clinical Data#

9.1 Clinical Data From Literature#

List all the clinical data you got from studies which matched your appraisal criteria.

9.2 Clinical Data from Clinical Study Databases#

List all the clinical data you got from studies (clinical, ANCTR, DRKS, WHO etc.).

9.3 Clinical Data From Adverse Event Databases#

List all the clinical data you got from studies which matched your appraisal criteria (BfArM, MAUDE, FDA Medical Device Recall, EUDAMED (when applicable)).

9.4 Summary and Appraisal of Clinical Data#

Summarize all the clinical data from above :)

9.5 Analysis of the Clinical Data#

Analyze the clinical data with a focus on whether your targets of clinical benefits and safety were fulfilled.

10. Equivalence#

NOTE: first of all, under the European MDR, equivalence data is not as significant anymore as it used to be under the MDD. That’s because the MDR now actually requires you to have access to the clinical data that you are referencing to support your own device’s safety and performance. Access to the data of competitor devices is usually rather tricky though. That’s why we’re using equivalence in our template only as a another indicator on the side.

It’s important though to understand why you’re conducting this equivalent device comparison: you want to show that another device is very safe and has a reliable performance. You then refer to those datapoints and, after demonstrating that your device is equivalent to the other, argue that those datapoints also support your device profile. That means:

  • Make sure to include search terms for the equivalent device(s), such as the brand name, in your literature search (para. 8)

  • Make sure to include search terms for the equivalent device(s), such as the brand name, in your literature search (para. 9)

You don’t really analyze the resulting information in the above paragraphs, but draw your main conclusion from this below in para. 10.2.4.

10.1 Equivalent Device#

Describe the equivalent device you’re comparing yourself to, mainly its Intended Use.

10.2 Demonstration of Equivalence (Technical, Biological, Clinical)#

Here you have to demonstrate that your device is equivalent to the Equivalent Device. You accomplish that by creating a table in which you list certain characteristics, and describe those characteristics both for the Equivalent Device and for your device. The idea is that your device is mostly the same in most characteristics.

The tables are split into general stuff (first table), then Clinical, Technical and Biological equivalence as per the guidance documents. I pre-filled some of the table rows for you as they should be universal, e.g., Intended Use, Medical Indication(s) and Programming Language. But definitely feel free to add additional rows which are useful for comparing your device to the equivalent one. Maybe you’re using recurrent neural networks and the equivalent device is, too? Then add that.

Equivalent Device

This Device

Intended Use

Medical Indication(s)

Device Classification

Principle of Operation

Stand-alone Software

Stand-alone Software

According to standard methodology, the level of similarity or equivalence of a comparable medical device to the evaluated medical device is divided into the three categories “clinical”, “technical” and “biological”.

Within each category there are four steps for the evaluation of the equivalence level:

Equivalence Level


Very Equivalent


Nearly Equivalent


In some aspects similar


In some aspects similar


After a score has been assigned to all three categories (clinical, technical, biological), those scores are summed up. The total equivalence is determined based on the sum of those values:




Very Equivalent


Nearly Equivalent


In some aspects similar


Very different

For software devices, adjust the score correspondingly. For example, you could say: “As the biological category typically does not apply for software devices, the total equivalence is determined based on the sum of those values as follows” and use an adjusted score: 6 // 5 // 3-4 // 0-2.

Clinical Equivalence#

The device is considered clinically equivalent if it is:

  • Used for the same clinical condition

  • Used for the same intended use

  • Used at the same site in the body

  • Used in a similar population

  • Not foreseen to deliver significantly different performances

  • Similar performances such as the expected clinical effect, the specific intended purpose, the duration of use, etc.

Technical Equivalence#

The device is considered technically equivalent if it:

  • Is of a similar design

  • Is used under the same conditions of use

  • Has a similar specifications and properties

  • Has a similar intensity of energy, tensile strength, viscosity, surface characteristics, wavelength

  • Has a similar surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions

  • Uses a similar deployment methods

  • Has similar principles of operation and critical performance requirements

Biological Equivalence#

For stand-alone software:

Not applicable. The device doesn’t come in contact with human tissue or body fluids.

For medical devices which are a part of a hardware medical device:

Note: Medical device monitors are also medical devices according to 60601-1.

The device is considered biologically equivalent if it:

  • Is similar or has similar effecting materials which are in contact with body tissue and fluids

Optional: Effectiveness Equivalence#

The device is considered to have equivalent effectiveness, if it:

  • Has similar Sensitivity, Specificity, Accuracy, NNP, PPV, etc.

10.2.1 Clinical Equivalence#

Note: The MDR doesn’t explicitly state that the device needs to be used for the same medical indication, gender and duration of use. But it should be used for the same clinical condition or purpose including similar severity and stage of the disease.

Equivalent Device

This Device

Clinical Condition

Disease Stage

Site in Body

Population: Age, Anatomy, Physiology

Clinical Effect

Duration of Use

Significant Performance Difference

Clinical Equivalence Score: <enter number between 0 and 3>

10.2.2 Technical Equivalence#

Equivalent Device

This Device

Software Algorithm

Programming Language

Graphical User Interface (GUI)

Web-based Application



The following table can be added if it is a hardware-related Medical Device:

Equivalent Device

This Device



Operating Condition

Physical Characteristics (e.g., weight)

Data transmission

Technical Equivalence Score: <enter number between 0 and 3>

10.2.3 Biological Equivalence#

For stand-alone software:

Not applicable. The device doesn’t come in contact with human tissue or body fluids.

For medical devices which are a part of a hardware medical device:

Equivalent Device

This Device

Material/ Radiation in Contact With Body (User/ Patient)

Biological Equivalence Score: <enter number between 0 and 3>

10.2.4 Conclusion#

Describe your conclusion based on the sum of the numbers values that you gave for each aspect of your equivalence evaluation.

It would be also good to describe, on a high level, the outcome of your evaluation from the following processes:

  • Risk Management

  • Biocompatibility investigation (if applicable)

  • Performance Testing

  • Usability Testing (formative / summative evaluation)

  • Post-Market Surveillance/ Post-Market Clinical Follow-up

Total Equivalence Score: <enter number between 0 and 9>

11. Post-Market Activities#

This chapter is used to summarize your PMS/ PMCF activities. During the clinical evaluation you evaluate the information of your safety and performance claims as well as general requirements on safety & performance. If you can not cover certain aspects you might need to add them to your PMS/ PMCF - Plan.

Summarize your post-market activities. You can copy-paste a lot of those here. At the minimum, you’ll have a Post-Market Surveillance Plan and Report. If this is your initial certification, your report may be empty as you haven’t brought your device to market yet.

Additionally, you may have a Post-Market Clinical Follow-Up (PMCF) Plan and Report which essentially has the content of “we’ll be tracking some data to make sure that our claims of clinical benefits and safety are actually true”.

Here’s what the guidance states about it: Describe how the manufacturer will verify the presumption that there would be no clinically significant difference in the safety and clinical performance of the device under evaluation compared with the equivalent device by post market surveillance or post market clinical follow-up?

  • PMS Plan

  • PMS Report

  • PMCF Plan

  • PMCF Report

  • PSUR (if relevant)

12. Conclusions#

Your conclusion is whether the clinical data shows that your goals (benefit/ performance and safety) are fulfilled. Reference your claims you stated before.

13. Date of the Next Clinical Evaluation#

When will you be doing the next clinical evaluation and updating this report?

14. Dates and Signatures#

Date and sign the report. If your document management system supports it, you can digitally sign by typing e.g., your initials in the “Signature” field. Otherwise, you can still sign it the old-school way (print it and sign the sheet of paper, ugh).







15. Qualification of the Responsible Evaluators#

Attach CVs of the people who were involved in writing the Clinical Evaluation. They must fulfil some criteria (it’s complicated), so I’ll just copy-paste MEDDEV 2.7.1 rev. 4 here:

  • The manufacturer defines requirements for the evaluators that are in line with the nature of the device under evaluation and its clinical performance and risks.

  • The manufacturer should be able to justify the choice of the evaluators through reference to their qualifications and documented experience, and present a declaration of interest for each evaluator.

As a general principle, the evaluators should possess knowledge of the following:

  • research methodology (including clinical investigation design and biostatistics); MEDDEV 2.7/1 revision 4 page 14 of 65

  • information management (e.g., scientific background or librarianship qualification; experience with relevant databases such as Embase and Medline);

  • regulatory requirements; and

  • medical writing (e.g., post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).

With respect to the particular device under evaluation, the evaluators should in addition have knowledge of:

  • the device technology and its application;

  • diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g., specialist clinical expertise in the relevant medical speciality).

The evaluators should have at least the following training and experience in the relevant field:

  • a degree from higher education in the respective field and 5 years of documented professional experience; or

  • 10 years of documented professional experience if a degree is not a prerequisite for a given task.

There may be circumstances where the level of evaluator expertise may be less or different; this should be documented and duly justified.

16. References#

Papers and other references which you cite go here.