How to Prepare Clinical Evaluation report CER under MDR

 

The EU MDR has fundamentally changed MDR clinical evaluation by moving from a document-focused approach to a lifecycle-based, evidence-driven framework. Under the MDD, manufacturers often depended on static CERs, literature summaries, and equivalence claims without regular updates.

Under MDR, clinical evaluation must be continuously planned, systematic, and transparent. It must confirm that a device’s safety and clinical performance remain acceptable when compared to the current state of the art, supported by solid clinical data.

Understanding how to prepare clinical evaluation report CER under MDR is essential. EU MDR 2017/745 requires manufacturers to follow Articles 61 and Annex XIV, ensuring that clinical evaluation is ongoing and evidence-based.

Manufacturers must demonstrate:

  • Intended clinical performance achievement
  • Data-supported clinical benefits
  • Acceptable and minimized risks
  • Continuous evidence validity

A CER is no longer a static file but a dynamic document that integrates device description, clinical claims, SOTA, literature review, risk–benefit analysis, and PMS/PMCF data into a unified evidence framework.

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