Clinical Evaluation Report Template

Our Clinical Evaluation Report Template will enable you to produce EU MDR-compliant CERs for your entire medical device portfolio

Features

  • 57-pages of expert guidance

  • Peer-reviewed by medical professionals

  • Full coverage of MDR CER requirements

  • A lifetime of free revisions

How it works

Our CER Template outlines an overall strategy and gives detailed guidance for writing each section of the CER.

  • Build each section by following instructions and answering questions using existing product information.

  • Employ the rules to identify, appraise and analyse clinical evidence for developing and using search protocols.

  • Use the specimen text to gain insight on wording, phrasing and emphasis.

What our customers say

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 Medical device software company, Europe

Comparison to free CER templates*

Using a free CER template or relying on MedDev guidelines may be tempting but often fails to meet requirements for writing an MDR-compliant Clinical Evaluation Report.

* Comparison made between our CER Template and the most searched for free options.
Feature

Free templates & MedDev 2.7/1 rev 4 guideline

Mantra Systems CER Template

Comprehensive Gives detailed general guidance Yes Yes
Literature review Guidance on identifying, appraising and analysing clinical data Yes Yes
CER structure Overall guidance on structure Yes Yes
Line-by-line guidance Step-by-step guide to every section of the CER with no gaps No Yes
Updated for EU MDR Updated to reflect changes introduced by MDR No Yes
Easy to use Enables immediate use following download No Yes
Examples Examples for each section showing correct language style and phrasing No Yes
Transposable text Blocks of text that can be used directly in the CER No Yes
Free automatic updates Regular updates emailed with enhanced guidance No Yes
Available support Access to specialist support at preferential rates No Yes

Exclusive CER Reviews

We also offer a CER review service at a preferential rate to buyers of our template. This optional service includes:

  • Direct feedback on your CERs from our MDR-trained medical team.

  • Identification of any gaps in your Clinical Evaluation strategy.

  • Ongoing support for Notified Body engagement.

Buy & Download

Get started today — our template is available for immediate download after purchase.

Current price: £1,650 (inc. VAT)

Single User Licence / PDF format

After purchase, you will be able to download your licenced copy immediately. You will also receive a confirmation email containing a link to download your copy. Your template can be opened by any PDF application.

to discuss:

  • payment through invoice
  • Multi User Licence pricing
  • our CER review service
  • any other purchase-related queries
Clinical Evaluation Report template PDF sample

Free sample

Do you need help with your MDR strategy?

Talk with us

Ask a question