Repeating findings often come down to one overlooked factor: weak CEP and CER templates.
Why do the same issues keep appearing in Clinical Evaluations? A recent discussion from a medical device expert in my network raised this exact question — and one explanation stands out again and again: poor templates for Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).
Why recurring Clinical Evaluation issues are no surprise
Over the years, I’ve reviewed many CEP and CER templates, and unfortunately, the same shortcomings show up every time.
Notified Bodies keep reporting similar findings for a reason: when templates are unclear or incomplete, the resulting documents inevitably reflect those gaps.
Here are the most common findings according to my experience.
1. CEP not aligned with Annex XIV Part A of the MDR
One of the most common issues is surprisingly simple: CEPs that do not cover all aspects required in Annex XIV Part A.
This leads to missing content, unclear rationales, or inconsistencies in the CER.
A straightforward fix: Structure your CEP so it directly follows every bullet point listed in Annex XIV Part A. This makes compliance obvious and much easier to demonstrate.
2. Inconsistent structure and lack of logical flow
Think of the CEP as the roadmap and the CER as the destination. If the CEP defines the structure, the CER should follow it consistently:
- Same terminology
- Same headings
- Same sequence
But many templates show a disconnect between the CEP and CER. The result is that reviewers struggle to follow the logic, and inconsistencies are identified as findings.
3. Too much repetition
Yes, the CER is supposed to be a standalone document.
But that doesn’t mean endless copy-paste from CEPs, search protocols, or State-of-the-Art reports.
Excessive duplication adds noise, buries your key messages, and makes the CER harder to review and to update.
Better approach: summarize, conclude, and reference.
4. Missing links to other processes
The clinical evaluation does not live in a silo — yet many templates act as if it does.
CER conclusions feed directly into:
- Risk management
- PMS and PMCF
- IFUs
- Claims and promotional materials
If your template doesn’t explicitly make these connections, they will be missing from your CER — and you’ll see it reflected in NB comments.
A Good template is a driver for quality
A well-designed template shapes the entire clinical evaluation process. It ensures clarity, consistency, and alignment with MDR expectations, and helps prevent the same issues Notified Bodies keep highlighting year after year.
If you want support updating your CEP/CER templates or reviewing your current structure, I’m happy to help — including a free initial consultation.