Significance of Equivalent Device in new MDR 2017/745 Medical Device CE Marking
A CE marked device from another manufacturer can be considered to be equivalent to the medical device undergoing clinical evaluation, if the two devices are comparable in their technical, biological and clinical characteristics. This means that the technical documentation of the equivalent device can be used to prove the clinical safety and performance of the device under evaluation. But, the equivalence between the devices has to be established through investigation and this demonstration of equivalence should be endorsed by the notified body.
According to MDR, to claim a device to be equivalent, there should be a contract in place between the manufacturer of the equivalent device and device under evaluation. Also, the manufacturer of the device undergoing clinical evaluation should be provided full access to the technical documentation of the equivalent device.
In case no claim of equivalency is made, literature obtained through search will have to be considered as the main source of clinical data to prove conformity to general safety and performance requirements. But these data might have low relevance during the appraisal.
DOES the manufacturer demonstrate the device equivalence to an already marketed device of another manufacturer?
If above is yes, then can be excepted from clinical investigation then below points has to be fulfilled in addition to above point
Yes, the manufacturer can demonstrate device equivalence to an already marketed device of another manufacturer, provided a contract is in place between the two manufacturers, as the blogger has mentioned.
As per the EU MDR, the clinical investigation can be exempted, if the demonstration of equivalency together with the clinical evaluation of the marketed device (performed as per the MDR), and clear evidence to the NB by the manufacturer would suffice and prove the conformity with relevant safety and performance requirements.
Demonstration of equivalence to an already marketed device has always been a practical way to prove that a new device is safe and effective also further additional clinical investigations may not be required.
As per EU MDR Annex XIV, Part A, In clinical evaluation technical, biological and clinical characteristics to be taken into account for demonstration of equivalence. In this case the manufacturer will have access to the data relating to the marketed device. Then, it will be easy to understand the technical documentation and decide the same will suffice or further clinical data is required to justify the claims of equivalence with regard to the safety and performance of the device.
In addition to above mentioned points by experts, to get exemption from Clinical Investigation in absence of demonstration of equivalence and clinical data for clinical evaluation, preclinical data and PMCF data can be used to prove the safety and performance of the device under evaluation.