Full Clinical Evaluation Report Template

Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology

Full Clinical Evaluation Report Template

Single one-off payment £795

Buy now

Also included in our discount bundle offers

  1. Clinical Evaluation Premium / Full price £1390 Discounted bundle price £1095

Step-by-step guidance for complete confidence

  • 64-page PDF document
  • Apply the principles of our successful Clinical Evaluation process to your CERs
  • Build each section by following simple instructions
  • Check your progress and phrasing using detailed examples
  • Implement targeted clinical evidence identification, appraisal & analysis
  • Streamline decision making and confidently select information for inclusion
  • Become an accomplished and confident CER writer

In more detail

Apply a successful Clinical Evaluation process across your entire medical device portfolio.

  1. This template is designed for QA/RA professionals with some technical writing experience who wish to produce EU MDR-compliant CERs in-house without the need for consulting support. It is also suitable for company founders and members of early stage start-ups who have undergone our CER Writing Training Course.

  2. Over 60 pages of unparalleled guidance, detailed examples, writing and style guides, providing full coverage of EU MDR CER requirements. It is in a format that has consistently gained Notified Body approval.

  3. Try it for yourself by working with the free CER sample.

  4. Please see the CER comparison chart.

  5. No - following purchase, it is yours to keep without any additional payments.

  6. You will have access to the CER Template under a Single User Licence. If you require access for multiple team members, please contact us about our Multi User Licences.

  7. The template opens with any PDF application and requires no activation or access codes.

Try a free sample

Download a free sample of our CER Template to see how it works.

Download sample

  1. Attain complete autonomy through a proven 14 section CER framework.
  2. Employ the rules to identify, appraise and analyse clinical evidence for developing and using search protocols.
  3. Build each section by following instructions and answering questions.
  4. Use the specimen text to gain insight on wording, phrasing and emphasis.
  5. Accelerate the production of high-quality Clinical Evaluation Reports and stay ahead of regulatory deadlines.

Clinical Evaluation Report template PDF sample Free sample

Our Customers say

  • A comprehensive, detailed and highly professional service.

    BG

    Regulatory Manager Manufacturer, UK

  • We were in the process of creating our first Clinical Evaluation Report and needed some guidance and examples. Your CER Template gave us a structure for our report and made decision making easier on what we should include. It certainly sped up our writing process and we would recommend it to others.

    PT

    Chief Product Officer SaMD Company, Europe

Comparison to free CER templates

Using a free Clinical Evaluation Report template or relying on MedDev guidelines may be tempting but often fails to meet MDR requirements.

* Includes the most searched for free options
Feature

* Free templates & MedDev 2.7/1 rev 4 guideline

Mantra Systems CER Template

CER structure outline

Overall guidance on structure

Yes Yes

Literature review process

Guidance on identifying, appraising and analysing clinical data

Yes Yes

Comprehensive & complete

Covers all MDR CER requirements

No Yes

Line-by-line guidance

Start-to-finish guide to every section of the CER

No Yes

Clear instructions

Step-by-step instructions for uncomplicated use

No Yes

Easy to use

Simple language and clear guidance

No Yes

Illustrative examples

Included in each section to show correct language style and phrasing

No Yes

Transposable text

Blocks of text that can be used directly in the CER

No Yes

Updated for EU MDR

Reflects the latest regulatory requirements

No Yes

Download today

You can download and use your document template immediately after purchase.

Full Clinical Evaluation Report Template

  • 64-page PDF document

Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology

  • Apply the principles of our successful Clinical Evaluation process to your CERs
  • Build each section by following simple instructions
  • Check your progress and phrasing using detailed examples
  • Implement targeted clinical evidence identification, appraisal & analysis
  • Streamline decision making and confidently select information for inclusion
  • Become an accomplished and confident CER writer
  • Also available to purchase in our bundle offers

Single one-off payment £795

Buy now

Bundle offers

We also offer reduced price bundles of related training courses and templates.

  1. Clinical Evaluation Premium

    Full price, bought separately £1390

    Discounted bundle price £1095

    Buy now

Prices shown exclude UK/EU VAT

  1. After payment you will get access to our Resources platform where all your purchases are stored.

    Invoices can be found in your Settings > Billing section.

Do you have any questions to ask our team?

Contact us