FREE CER Template

Simplify your Clinical Evaluation Reports for any class of medical device using our proven CER structure

FREE

Clear, easy-to-follow structure to help you get started

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

Who is this template for?

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 initial 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.
What is included?

22 pages of clear, structured guidance, simple examples, and writing tips, covering key EU MDR CER requirements. Designed to help you stay on track and meet essential regulatory expectations.
How will I know it's right for me?

You'll know it is right for you if you need a simple, structured guide to help you get started on your CER.
How does this compare with other CER templates?

If you're looking for more detailed examples and in-depth regulatory coverage, please take a look at our full CER Template.
What is the file format?

This free template opens with any PDF application and requires no activation or access codes.

Download & Review the Structure Download the free template and familiarise yourself with the template’s sections, each aligned with MDR requirements.
Follow Section Instructions Complete each section based on the simple, clear instructions provided.
Identify Key Clinical Evidence Follow the guidance to include relevant clinical evidence for your device.
Review & Finalise Edit your CER for clarity, completeness, and regulatory alignment before saving.

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

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

FREE