Clinical Evaluation Report (CER) for MDR: Structure, Strategy, and Compliance

Understanding the Clinical Evaluation Report (CER)

When it comes to medical devices, proving clinical safety and performance is not just good practice, it’s a regulatory requirement. The Clinical Evaluation Report (CER) is the document that systematically collects and evaluates all available clinical data to demonstrate compliance with EU Regulation 2017/745 (MDR) and support CE marking.

More than a collection of scientific papers, the CER is a central element of a manufacturer’s market access strategy. In this article, we explain what a Clinical Evaluation Report really is, what it must include, and why it plays a vital role in MDR compliance for medical devices.

The Role of the CER in Achieving CE Marking

The CER is a key component of the technical documentation and the manufacturer’s quality management system. It must align with:

• the risk management file,

• the post-market surveillance (PMS) plan,
• the post-market clinical follow-up (PMCF) plan,
• the instructions for use (IFU) and labeling,
• and of course, with the MDR.

Key components of a Clinical Evaluation Report under MDR

What the CER must include:

According to the MDR and MDCG guidelines (especially MDCG 2020-13), a complete CER should include the following sections:

1. Device Description and Intended Clinical Use
2. State of the Art and Comparison with Existing Alternatives
3. Literature Review Methodology Aligned with MDR
4. Critical Appraisal of Available Clinical Data
5. Benefit-Risk Evaluation
6. Link to PMS and PMCF Activities
7. Clinical Conclusions Confirming MDR Compliance

The role of equivalence in a Clinical Evaluation Report

One of the most sensitive sections of a CER is the demonstration of equivalence with other devices. This is only acceptable when the comparator device shares clinical, technical, and biological characteristics. For implantable or Class III devices, manufacturers must have contractual access to the technical documentation of the equivalent product.

Systematic literature review: a proper MDR-aligned approach

A CER cannot rely on a generic literature search. It must follow structured and reproducible methodologies (e.g., PRISMA, PICO, MOOSE). Sources should include both positive and negative data, and cover the evaluated device, potential equivalents, and comparable products that define the current “state of the art.”

Clinical Investigations and PMCF in the Clinical Evaluation

When clinical data are limited or absent, the manufacturer must justify this and implement an appropriate PMCF plan. The absence of a clinical investigation does not exempt the manufacturer from conducting a thorough clinical evaluation, in fact, it requires an even more robust and justified strategy.

The Notified Body’s role in CER review

The Clinical Evaluation Report is assessed by the Notified Body through a Clinical Evaluation Assessment Report (CEAR). This review verifies:

• the relevance and adequacy of clinical data;
• proper demonstration of equivalence;
• a favorable benefit-risk ratio;
• alignment of PMS and PMCF with clinical conclusions.

Conclusion

Preparing an effective CER is a crucial step to ensure the device’s quality, reliability, and MDR clinical compliance.

A well-prepared CER supports not only CE marking but the entire product lifecycle in a transparent and documented way.

Need guidance preparing your Clinical Evaluation Report? We can help you define the most effective strategy to align with MDR requirements and technical documentation.