The EU Medical Devices Regulation (MDR) 2017/745 has made clinical evaluation an ongoing obligation for all device classifications. Preparation is essential to meeting the MDR’s expanded definitions, evidence thresholds and documentation requirements.
To help medical device manufacturers meet these demands and achieve and maintain market access, this white paper delivers expert insights and practical guidance for building compliant documentation processes, addressing common issues and navigating ongoing obligations with confidence.
You’ll gain practical guidance on:
The MDR’s latest clinical evaluation requirements and their impact on device manufacturers
Key steps for developing compliant Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
Common issues with clinical evaluation documentation and recommendations for addressing evidence gaps
Best practices for preparing a CER and maintaining compliance throughout the life cycle of your medical device
Clinical Evaluation for Medical Devices
330.31 KB
Download the white paper for an overview of how you can meet the MDR’s clinical evaluation requirements while avoiding preventable delays.
You’ll also learn how to incorporate effective post-market clinical follow-up (PMCF) strategies to strengthen your evidence base, support regulatory compliance and protect your devices’ position in the market over time.
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