Hi,
According to MDR, "In the case of accessories to medical devices, despite not being medical devices per se, they are covered by MDR provisions and fall under the term “device” in the meaning of the MDR. However, accessories to devices covered by the MDR by virtue of its Annex XVI are not covered by the MDR."
In such a case, if I have a Class I accessory to Class IIa medical device, does the accessory must be in compliance with MDR as of 26/05/2021 (as class I medical devices) or the accessories can be evaluated according to MDR along with the medical device?
Thanks,
Yana
According to MDR, "In the case of accessories to medical devices, despite not being medical devices per se, they are covered by MDR provisions and fall under the term “device” in the meaning of the MDR. However, accessories to devices covered by the MDR by virtue of its Annex XVI are not covered by the MDR."
In such a case, if I have a Class I accessory to Class IIa medical device, does the accessory must be in compliance with MDR as of 26/05/2021 (as class I medical devices) or the accessories can be evaluated according to MDR along with the medical device?
Thanks,
Yana