Clinical Evaluation Report Template
Our Clinical Evaluation Report Template will enable you to produce EU MDR-compliant CERs for your entire medical device portfolio
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.
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 CER.
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 Review service
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.
- payment through invoice
- Multi User Licence pricing
- our CER review service
- any other purchase-related queries