How to Smartly Write a Clinical Evaluation Under the EU MDR

The clinical evaluation is seen by many as just another document within the device’s technical documentation — often left for the end, treated as a standalone report whose output is rarely linked back to other sections. However, it is much more than that. The Clinical Evaluation Report (CER) is not just a compliance requirement; if developed strategically, it can become a powerful tool that feeds into the device design, risk management, IFU, clinical planning and business development. 

Whether you are a manufacturer of a legacy device or of a device that has not yet been CE marked, the following tips will help you write a smarter, more valuable clinical evaluation as required by the EU MDR:

1. Start early.

Begin your clinical evaluation early in the device lifecycle, ideally in parallel with drafting other technical documents. This will ensure that the CER is not only aligned with your design, IFU, risk management and PMS documentation but can also contribute to the development of these documents. An early start allows you to identify data gaps sooner and plan how to address them, rather than discovering them too late in the process. 

2. Perform a smart literature search first.

The systematic literature search for device publications, similar devices, alternative treatments and clinical background is one of the foundational pillars of the CER and one of most time-consuming parts. Design your literature search smartly from the start, with clearly defined objectives, search strings, inclusion, exclusion and appraisal criteria. It will maximize the value of the data you collect while avoiding an unmanageable volume of irrelevant data. Performing this search as one of the initial clinical evaluation activities can bring important insights: 

• You may identify published data on your device that you weren’t aware of, find that your device represents standard of care among alternatives, or identify an equivalent device with extensive clinical data. This helps refine your clinical evaluation strategy.
• If you are planning a clinical investigation, the literature search can offer input on established clinical outcome parameters (endpoints) and expected acceptance criteria by reviewing similar device data. 
• Literature search results provide input to your risk management and IFU. They may reveal clinical risks or adverse events not previously considered, confirm that known risks are well mitigated in clinical practice, or help define risk rates. Additionally, it will help you verify if your IFU includes warnings or precautions that are justified by clinical evidence.

3. Plan ahead for data gaps.

During your evaluation, you may identify missing or insufficient data to support certain claims. If you start your clinical evaluation early, you can plan for these gaps proactively instead of discovering them when it’s too late to act. Whether you are planning to address them through a PMCF study, survey, or real-world evidence collection, acknowledging data gaps and outlining a plan to close them demonstrates proactive compliance and maturity in your clinical strategy. 

4. Use the CER as a strategic Tool.

The CER should be seen as a strategic asset, not merely a regulatory deliverable. When approached smartly, it ensures MDR compliance while creating tangible value for other departments across the organization. Its outputs can inform decisions such as: 

• Clinical: Clinical trial design and the selection of meaningful endpoints for future studies. 
• Marketing: Development of marketing claims that are realistic and supported by clinical data.
• Business Development: Competitive positioning, understanding how your device compares with similar products and available alternatives. 

• 5. Keep the CER up-to-date using PMS and PMCF.

  Under the MDR, the clinical evaluation is not a one-time exercise. It needs to be continuously updated throughout the device lifecycle with PMS/PMCF data. Think of your CER as a living document that evolves with your product. To make CER updates easier and more efficient, link your CER directly to your PMS and PMCF activities. Many of these activities, such as updating literature searches or reviewing vigilance data, overlap with the CER, allowing you to keep it current with minimal extra effort. 

The CER is not just a box to tick in your technical documentation. By starting early, designing literature searches smartly, planning for data gaps, integrating PMS/PMCF, and thinking strategically, your CER becomes a living, actionable document that informs product development, risk management, regulatory compliance, and market strategy. 

Ready to Get More Value from Your CER? 

By approaching your clinical evaluation strategically, you can transform it from a compliance exercise into a living document that actively supports your product lifecycle. A well-planned CER not only satisfies MDR requirements but also strengthens your device design, risk management, and post-market surveillance. It connects regulatory compliance with real business value, helping your organization make data-driven decisions with confidence. 

If you’re looking to strengthen your clinical evaluation process or want expert guidance in developing a compliant and value-driven CER, our Qserve clinical and regulatory experts are here to help. Get in touch with us to learn how we can support your team in turning your CER into a true strategic asset.