EU MDR CER Requirements in 2025
Key Changes, MDCG Guidance & How to Stay Compliant
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.
1. From MDD to MDR: What’s New in Clinical Evaluation Requirements
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.
2. Essential MDCG Guidance: 2020-2024 Overview
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:
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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.
3. Transition Deadlines & Regulatory Amendments
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:
- Before placing a device on the market
- Before making signifcant design changes
- If required by your Notified Body or Competent Authority
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.
4. Top CER Findings in 2024-2025
Audit findings and Notified Body feedback in 2024 show a clear pattern based on our experience. Common issues include:
- Unclear objectives: Safety and performanc objectives that are vague or generic, and that lack measurable, quanitfiable, or device-specific acceptance criteria.
- SOTA weaknesses: A state of the art that does not adequately address the currently accepted state of the art or methods of intervention related to the identified medical condition due to an outdated or poorly justified literature review.
- Equivalence misuse: Relying on competitor data without documented access or clear comparibility; misunderstanding the difference between "similar" and "same", and/or failing to approach equivalence from a technical, biological, or clinical perspective.
- Gaps in clinical evidence: Missing or insufficient data without a documented plan or justification, or the lack of a robust post-market plan.
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."
5. Your 2025 CER Compliance Checklist
To ensure you are prepared, use the following checklist:
- Conduct a gap analysis against Annex XIV and relevant MDCG guidance
- Clearly state what metrics you will assess for safety and performance. State your methodology for how you will determine if your device is safe and performs as intended.
- Use systematic literature reviews with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) methodology, and a justified search horizon (ex. length of device's time on the market or time since last search for subject device literature).
- Rigorously document equivalence or prepare for a clinical investigation (if needed for your deivce). Ensure adequate clinical data and provide justification; clearly explain any regulatory strategy and planned/ongoing evidence collection
- Plan fo ongoing sustain work inclueding a robust PMS/ PMCF apprach
- Ensure cross-functional alignment across all documentation: Confirm that current clinical data, conclusions, device descriptions, and revisions histories are consistent across the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Risk Management File, Post-Market Surveillance (PMS) Plan, Post-Market Clinical Follow-up (PMCF) Plan, Summary of Safety and Clinical Performance (SSCP), and product labeling. Misalignment across these documents is a frequest source of Notified Body findings.
- Implement and document a CER update schedule based on device class and trigger events.
6. Need Help?
GLOBAL's regulatory writing team delivers end-to-end support to ensure your CER is compliant, audit-ready, and strategically aligned. Our services include:
- Systematic literature reviews with reproducible methods
- Full CER drafting and formatting
- Notified Body response strategy and authoring
- Full portfolio scoping and project management
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.
