7. Equivalence

Source: CER Template.pdf page 18 (document: Mantra Systems Free CER Template, Edition 2)

This section is only applicable when equivalence is being claimed.

Equivalence is the process of using clinical data from other devices, claimed to be equivalent to the subject device, to provide evidence of the safety and performance of the subject device.

Equivalence must be demonstrated in three domains:

1. Clinical characteristics
2. Technical characteristics
3. Biological characteristics

7.1 Equivalent device(s)

Name the equivalent device(s) and give details of the manufacturer(s).

7.2 Statement of equivalence & access to data

Write a declaration that the base requirements for claiming equivalence under MDR have been met (assuming this is true). A rationale for justifying sufficient access to equivalent device information must be set out. For Class III devices claiming equivalence to another manufacturer's product, a contract must also be in place granting full access to the equivalent device technical files.

7.3 Equivalence rationale -- technical, biological and clinical characteristics

A comparison of technical, biological and clinical characteristics of the subject and equivalent device should be set out, normally in table form. For each line item, include an assessment of the impact of any differences on safety or performance. Ensure that determinations are evidence-based and justified.

Characteristic	Subject device	Equivalent device	Difference and impact on safety/performance
Technical	_____	_____	_____
Biological	_____	_____	_____
Clinical	_____	_____	_____

7.4 Equivalence summary

Summarise this section with a set of conclusions about equivalence.

Conclude whether equivalence is demonstrated or not. If it is, conclude and confirm that the differences between the devices are not expected to affect the clinical performance and clinical safety of the device under evaluation. Include a description of any limitations and gaps in the equivalence assessment.