Clinical evaluation requirements have intensified under the European Union (EU) Medical Devices Regulation (MDR) 2017/745. Although the Clinical Evaluation Report (CER) is still submitted at defined intervals, MDR requires manufacturers to present a more rigorous, continuously substantiated body of clinical evidence than was required under the Medical Devices Directive (MDD). A compliant CER must now clearly demonstrate how the clinical evidence was gathered, analyzed, and interpreted; substantiate every claim of safety and clinical performance with current clinical data; and show explicit alignment with post market surveillance (PMS), post market clinical follow up (PMCF), and risk management documentation. The CER must be regularly updated; the cadence of which is dependent on the risk of the device and its classification. Each evaluation cycle and revision must confirm that the benefit risk profile remains favorable throughout the device life cycle. In effect, the CER has become the cornerstone of the technical documentation, integrating pre-market and post-market evidence to satisfy Article 61and Annex XIV. Critically, post-market data should now also include real-world evidence where available.
In this post, we break down the regulatory evolution, highlight critical Medical Device Coordination Group (MDCG) guidance, and outline practical steps to help you pass Notified Body scrutiny with confidence in 2025.
Since 26 May 2021, when the Medical Devices Regulation (EU)2017/745 became fully applicable, manufacturers have been held to significantly higher clinical evidence standards. Article 61 and Annex XIV, Part A establish clear requirements for a proactive, documented, and risk-adjusted approach to clinical evaluation.
Some key shifts include:
These changes require new thinking—not just minor updates. Manufacturers must revise templates, enhance review protocols, and ensure consistent alignment across technical documentation.
MDCG guidance documents provide clarity on interpreting the MDR’s clinical evaluation rules. While not legally binding, Notified Bodies treat these guidance documents as authoritative, and failure to implement MDCG recommendations can result in Notified Body findings or rejections.
Here’s a snapshot of the most impactful guidance and its practical implications:
.png)
Takeaway: Incorporate MDCG guidance into your CER strategy. Templates, checklists, and internal training should be regularly updated to reflect evolving guidance.
GLOBAL offers tailored training programs for internal writing teams to ensure your staff stays up to date with current CER requirements, MDCG guidance, and best practices for documentation and compliance. Our team is fully up to date on current MDCG guidance and has the expertise to apply them effectively in regulatory writing and strategy.
The 2023/607 Regulation granted MDR transition extensions for legacy devices (until 2027-2028), but these deadlines do not mean CER updates should be delayed. You still need an MDR-compliant CER:
Delays in producing an MDR-compliant CER may risk market interruptions or audit findings that are difficult to remediate. Notified Bodies are currently facing significant backlogs for MDR reviews, particularly for legacy devices nearing transition deadlines. Submitting early is critical to ensure timely review and to maintain uninterrupted market access for legacy devices.
Audit findings and Notified Body feedback in 2024 show a clear pattern based on our experience. Common issues include:
For deeper insights into what Notified Bodies are looking for in clinical evaluations, read our companion article: "Notified Body Insights: What They Expect in Your CER."
To ensure you are prepared, use the following checklist:
GLOBAL's regulatory writing team delivers end-to-end support to ensure your CER is compliant, audit-ready, and strategically aligned. Our services include:
We also help evaluate your full device portfolio, identify documentation gaps, and build MDR-ready clinical evidence tailored to your device’s class and risk profile.
Contact us today to accelerate your CER development and avoid costly delays.
Understand what a Clinical Study Report (CSR) is and why it’s critical for regulatory submission. Learn how the ICH E3 guideline shapes its structure and how expert medical writing ensures clarity, compliance, and approval-readiness.
Generative AI tools are starting to revolutionize how many industries engage with regulatory obligations. We discuss the opportunities and challenges in working with AI, and outline how our team of medical writers can support your project to ensure quality submissions.
GLOBAL is a leading partner for regulatory writing and consulting, and in this post, we discuss key considerations for determining when to retain work internally and when to engage a trusted third-party partner.
