Clinical Evaluation Reports (CERs) are one of the most scrutinized components of European Union Medical Device Regulation (EU MDR) submissions and one of the most common sources of Notified Body deficiencies. Even experienced manufacturers can find themselves facing costly rework due to avoidable issues like vague safety objectives, incomplete state-of-the-art benchmarking, or unsubstantiated equivalence claims. In this post, we outline the most frequent CER findings cited by Notified Bodies and offer practical strategies to help you avoid them.
Notified Bodies have repeatedly indicated that clinical evaluations and clinical investigations are the single most frequent source of MDR non-conformities across all device classes, outpacing Quality Management System (QMS), risk management, and labeling issues combined. A review of recent deficiency letters and white-papers shows the same pattern: Notified-Body reviewers are still flagging predictable, repeatable weaknesses in CERs. Here, we highlight common NB findings based on our own extensive experience to help shorten your review cycles, lower remediation costs, and protect your launch timelines.
Notified Bodies note that safety and performance objectives that lack Specific and Measurable Outcomes (SMOs) top the deficiency list. Vague endpoints (e.g., “demonstrate safety”) are difficult to quantify or measure and Notified Body reviewers may want to see your evidence in more measurable terms. Similarly, safety and performance objectives should be identified with clear acceptance criteria. Reviewers want to see that you understand how your device fits within the therapeutic landscape and clear acceptance criteria helps you show this.
Example question:
The safety objective is shown below. Would you please provide a more granular and quantified safety objectives, from identified top serious AEs associated with non-vascular procedures, with a quantitative acceptance criteria for each (with justification)?
Notified bodies repeatedly ask, “What does good look like?” Essentially, Notified Bodies want to see you think critically about your device and ensure you’re placing it within the currently accepted state of the art. Without a comprehensive State of the Art (SOTA) the reviewer cannot judge if your outcomes are clinically acceptable.
Devices often have broad clinical indications, but you may only have evidence for a subset of indications. Notified bodies flag that disconnect: “Intended purpose statement is incomplete; clinical indications are unclear,” or “Evidence does not support the full breadth of the intended purpose.”
Reviewers expect the data to map to every combination of patient type, indication, and device variant covered by the label. Failure to stratify your evidence may lead to findings such as “Clinical data have not been appropriately stratified against the intended patient populations, treatment indications, device variants and combinations.”
Checklist:
This common Notified Body finding is often phrased as: “It is not clear that systematic search methods have been used for the literature review.”
What reviewers expect:
Medical Device Coordination Group (MDCG) 2020-5 reminds manufacturers that all three pillars—technical, biological, and clinical characteristics—must be similar or the same before equivalence can be claimed, and the CER must show full access to data for the reference device.
Best practice
Even when your collection of clinical data looks favorable, reviewers frequently conclude: “Benefit–risk conclusion is not justified in relation to the SOTA.”
Avoid this by:
Deficiencies often cite “The PMCF plan does not address residual risks” or reject blanket statements that no PMCF is necessary.
What we’ve seen work:
The patterns above account for the vast majority of CER deficiencies cited by BSI, TÜV SÜD, NSAI, and other notified bodies over the past two years. Addressing them proactively can:
GLOBAL’s writers have resolved hundreds of such findings and incorporate these lessons into every CER we author or remediate. If your team would like an independent gap assessment, or hands-on support to close identified gaps, reach out to us at info@globalrwc.com.
For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. This initiative is designed to help sponsors of certain accelerated development products better align their CMC strategies with the FDA early in the development process.
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable. Yet, while the science is groundbreaking, the CMC (Chemistry, Manufacturing, and Controls) pathway remains one of the most significant obstacles to timely regulatory approval.
