Insights for the Robust Clinical Evaluation Report (CER) for EU MDR

Insights for the Robust Clinical Evaluation Report (CER) for EU MDR | Eclevar MedTech

Why is Writing the CER Under EU MDR Challenging?

Compared to the MDD, MDR expects a higher standard for the CER. MedDev 2.7/1 rev4 has not been updated according to MDR 2017/745. Therefore, writers of CERs need to largely rely on their own expertise and insights to prepare CERs that meet all expectations and standards of the MDR.

While some CER templates are available, not all fit your specific products as requirements differ by device type. If there were a one-fit-all, versatile template, writing CERs would be easy and efficient. However, none currently exists, though standard templates for certain device types may emerge in the future.

Key Understanding

The MDR is structured so that the CER for your product must be uniquely tailored to your device. This may seem daunting if you're not confident in writing CERs according to MDR requirements and standards. However, with proper expertise and guidance, you can navigate this successfully.

Tips for Writing a Robust CER

Make It Reviewer-Friendly

Notified Body reviewers are human and not necessarily experts in your device category. Design your CER structure to be easy to navigate. Use clear bookmarks to help reviewers find reference documents quickly and avoid redundancy throughout the document.

Ensure Consistency

All documents must be consistent, including the CER, IFU, product catalogue, and technical documents. Use the same terminology across all documents. If terms differ between the IFU and CER, you'll likely receive deficiency feedback from NBs unless the differences are obviously intentional.

Conduct Thorough SOTA Evaluation

Evaluate not only benchmark products but also all alternative therapies and procedures currently used for your target indications. A thorough State-of-the-Art (SOTA) evaluation is critical. Insufficient SOTA evaluation is a common reason for NB deficiency feedback.

Define Clinical Outcomes

Once you define clinical claims (both performance and safety), establish clinical outcomes for each claim with threshold values. Your device will be measured against the SOTA using these thresholds. Base threshold values on your SOTA evaluation.

The Critical Role of Clinical Claims

Clinical claims are the most important and core element of your CER as they shape the entire clinical evaluation. If clinical claims are not well defined, it becomes difficult to identify proper SOTA, create appropriate literature search protocols, and conduct sufficient literature search and SOTA evaluation.

Definition of State-of-the-Art (SOTA) per MDCG 2020-6:

"Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience."

What Level of Literature Search and SOTA Evaluation is Expected?

Once clinical claims are defined, you must identify proper SOTA based on those claims. The EU MDR requires and expects thorough clinical evaluation. This means:

Systematic Literature Search Requirements

Conduct a systematic search with a justifiable protocol
Include clear inclusion and exclusion criteria
Define the search period explicitly
Include all search results, even if no literature is found
Document that you have conducted a thorough search for the NB
Identify missing or insufficient clinical evidence
Plan PMCF activities to collect missing evidence if you want to maintain clinical claims

The EU MDR expects CERs with higher standards compared to the MDD. CER writers need to be highly skilled with expertise and good understanding of NB expectations. If you're not confident, it's highly recommended to consult with an expert.

Need Help with Your CER?

Navigating the complexities of EU MDR compliance can be challenging. At Eclevar MedTech, our experts specialize in crafting high-quality Clinical Evaluation Reports (CERs) that meet the rigorous expectations of Notified Bodies.

Key Takeaways

EU MDR requires higher CER standards compared to MDD, with no updated MedDev 2.7/1 rev4 guidance
CER writers must rely on expertise and insights to meet MDR expectations
No one-size-fits-all CER template exists; each CER must be uniquely tailored to the specific device
Notified Body reviewers are human and not necessarily experts in your device category
CER structure should be easy to navigate with clear bookmarks and minimal redundancy
Consistency in terminology across all documents (CER, IFU, product catalogue, technical documents) is critical
State-of-the-Art (SOTA) evaluation must be thorough and include all alternative therapies and procedures
Clinical claims are the core element that shapes the entire clinical evaluation
Clinical outcomes must be defined for each clinical claim with threshold values based on SOTA
Literature search must be systematic with justifiable protocols, inclusion/exclusion criteria, and defined search periods
All search results must be included, even if no literature is found, to demonstrate thoroughness
Insufficient SOTA evaluation is a common reason for Notified Body deficiency feedback
PMCF activities should be planned to collect missing or insufficient clinical evidence
CER writers need to be highly skilled with good understanding of NB expectations
Consulting with experts is highly recommended if you lack confidence in CER writing

Webinar Replay Available: "How to Avoid Notified Body CER Rejections"

Notified Bodies are tightening their requirements, and many Clinical Evaluation Reports (CERs) face rejection under EU MDR. Want to know how to avoid common pitfalls and secure NB approval?

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Partner with Eclevar MedTech

Eclevar MedTech is a CRO specialized in medtech industries with extensive experience in preparing CERs under EU MDR. If you have any difficulties with your CERs, please feel free to contact us at clientcare@eclevar.com.