When Your Marketing Says More Than Your Evidence Can Defend
A Notified Body reviewer opens your technical documentation. The IFU promises faster recovery. The website highlights superior safety. The marketing brochure uses
The gap between what manufacturers say about their devices and what their clinical evidence actually demonstrates is one of the most frequent deficiencies I encounter during audits and reviews. It is also one of the most dangerous.
Because when marketing claims exceed clinical evidence, you are not just facing a documentation issue. You are facing a compliance failure that puts the entire conformity assessment at risk.
The Regulatory Foundation: Intended Purpose Under MDR
Under MDR Article 2, the intended purpose is defined as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials or statements. This is not a minor definition.
It means that everything you say about your device—in the IFU, on your website, in your sales presentations, in your training materials—becomes part of the intended purpose. And the intended purpose must be supported by clinical evidence.
This is the link that manufacturers often underestimate. Marketing teams create claims. Sales teams amplify them. Technical teams approve them without checking whether the clinical evaluation actually covers those claims. Then the Notified Body asks for evidence, and the misalignment becomes visible.
Every claim made about your device in any form of communication—labels, promotional materials, training documents—directly shapes the intended purpose and must be clinically substantiated. Marketing and clinical evidence must be checked against each other before any material is released.
But the problem goes deeper than most regulatory professionals realize.
How the Disconnect Happens
In most organizations, clinical evaluation and marketing operate in separate worlds. The clinical affairs team prepares the CER based on available literature and clinical data. The marketing team creates materials based on competitive positioning and customer needs. The two streams rarely meet until submission.
I have reviewed files where the marketing brochure mentions specific patient populations that were never addressed in the clinical evaluation. Where the website claims
Frequently Asked Questions
What is a Clinical Evaluation Report (CER)?
A CER is a mandatory document under MDR 2017/745 that demonstrates the safety and performance of a medical device through systematic analysis of clinical data. It must be updated throughout the device lifecycle based on PMCF findings.
How often should the CER be updated?
The CER should be updated whenever significant new clinical data becomes available, after PMCF activities, when there are changes to the device or intended purpose, and at minimum during annual reviews as part of post-market surveillance.
What causes CER rejection by Notified Bodies?
Common reasons include inadequate equivalence demonstration, insufficient clinical data for claims, poorly structured SOTA analysis, missing gap analysis, and lack of clear benefit-risk determination. Structure and logical flow are as important as the data itself.
Which MDCG guidance documents are most relevant for clinical evaluation?
Key documents include MDCG 2020-5 (Equivalence), MDCG 2020-6 (Sufficient Clinical Evidence), MDCG 2020-13 (CEAR Template), MDCG 2020-7 (PMCF Plan), and MDCG 2020-8 (PMCF Evaluation Report). MDR Article 2, MDCG 2020-6
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Peace, Hatem
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Deepen Your Knowledge
Read Complete Guide to Clinical Evaluation under EU MDR for a comprehensive overview of clinical evaluation under EU MDR 2017/745.
