Under the Medical Devices Regulation (MDR, EU 2017/745), clinical data generated by another device and published in the scientific literature which meets the MDR definition of clinical data, may be used to support the safety and/or performance of a device if both devices have been demonstrated to be equivalent.
The MDR defines in Annex XIV, Part A, Section 3 how equivalence must be demonstrated. A determination of equivalence must be based on a systematic comparison of the technical, biological, and clinical characteristics of the device under evaluation and the potentially equivalent device, to the extent that there is no clinically significant difference in safety and clinical performance between the two devices
In most cases, the manufacturer must also have sufficient levels of access to the data on the other device to verify the comparison. For implantable and class III devices, if equivalence is claimed to a device not manufactured by the same company in order to avoid conducting a new clinical investigation, there must be a contract in place granting full ongoing access to the technical documentation of the other device. Where no such access exists, equivalence cannot be used for conformity assessment.
The use of clinical data from equivalent devices remains an important means of meeting EU clinical data requirements. However, in recent years, demonstrating equivalence has become increasingly challenging. Notified Bodies are more frequently rejecting equivalence rationales, especially where sufficient access to data cannot be shown or where one or more of the three MDR equivalence characteristics are not fully met.
As a result, manufacturers may need to conduct a clinical investigation before a CE mark can be obtained under the MDR or to maintain CE marking for a device being transitioned from the previous directives to the MDR. This can be particularly frustrating when a device is based on well-established technology and strong evidence of safety and performance can be demonstrated through non-clinical testing, or when the device has been on the market for many years without unacceptable clinical safety or performance concerns.
DLC can help you to:
- Determine equivalence between your device and one or more potentially equivalent devices in accordance with MDR requirements and expectations
- Where needed, develop a robust equivalence rationale for submission to a Notified Body
- Correctly interpret the MDR requirements regarding equivalence, which are often misunderstood and misapplied
