MDR requirements for Class I accessories

#1
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
 
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#2
Hi Yana,

Unfortunately, the MDR is not very specific to this case. However, it is clear in saying that an accessory to a medical device should be considered to be a medical device in its own right, and shall meet the requirements of the MDR. So if your accessories were classified as Class I under the MDD and will remain Class I under the MDR, they would need to transition to the MDR by 26 May 2021.

This of course does bring with it quite a lot of issues, especially with meeting the technical documentation requirements of Annexes II and III. When putting together these documents, just keep in mind to keep them proportionate to the overall risk of these accessories.
 
#3
Hi Yana,

Unfortunately, the MDR is not very specific to this case. However, it is clear in saying that an accessory to a medical device should be considered to be a medical device in its own right, and shall meet the requirements of the MDR. So if your accessories were classified as Class I under the MDD and will remain Class I under the MDR, they would need to transition to the MDR by 26 May 2021.

This of course does bring with it quite a lot of issues, especially with meeting the technical documentation requirements of Annexes II and III. When putting together these documents, just keep in mind to keep them proportionate to the overall risk of these accessories.
Thank you very much for the explanation. Sounds reasonable.
 
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