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:

  • 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).

1. Relevant Documents#

  • SOP Clinical Evaluation

  • Clinical Evaluation Report


  • Name: <product name>

  • Version: <product version>

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


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

  • Author

  • Literature search

  • Evaluation of complaints, customer feedback

  • Review

2. Scope of the Clinical Evaluation#

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

2.1 Device Description#

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

2.2 Clinical Benefits, Outcome Parameters#

Describe the clinical benefits you expect from your product. Define how you’ll measure those (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.

Also describe the product claims as stated by MEDDEV 2/7.1 Rev. 4, as stated there: 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. e.g.

  • diagnosis for better treatment decision (performance)

  • xy % accuracy, xy % sensitivity, xy % specificity

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.

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. In 99% of cases as a startup, you’ll be claiming equivalence to an already-certified (CE marked) device. You’ll have some methodology for searching for such a device. If you need some inspiration, check out the FDA 510k database for FDA-approved devices which claim equivalence to an already-certified device. Those are usually good to compare clinical and technical features and demonstrate equivalence :)

And based on that, you’ll be doing a literature search to come up with adequate clinical data.