Equivalence Table for Clinical Evaluation Usage

Download a free template (MS Word)

Medical device manufacturers will benefit from using this equivalence table to demonstrate conformity of their medical device with all MDR requirements on general safety and performance. This template enables manufacturers to reduce spending on clinical studies by using existing clinical data related to an equivalent device during the clinical evaluation in order to ensure conformity with relevant general safety and performance requirements.

This equivalence table helps manufacturers to:

• Clearly state all differences between the devices
• Analyze these differences to calculate the impact they might have on safety and performance
• Include relevant device illustrations that highlight similarities and differences