Rental and MDD versus MDR

JoCam

Trusted Information Resource
#1
Hi All,

We manufacture class I medical devices for sale and rental. For rental devices that are no longer being manufactured, would we be expected to ensure stock is MDR compliant after 26th May, and therefore ensure technical files, labels and IFU's are updated?

JoCam
 
Elsmar Forum Sponsor

mboynton

Starting to get Involved
#2
Dear JoCam,

I'd recommend consulting the Blue Guide to see if you can find helpful guidance there, if you've not already done so.

MDR compliance is required for class I devices starting May 26th, if the exemptions allowed under the 2nd Corrigendum don't apply, and if the devices have not already been placed on the market. In the case of rented devices, if your rental stock consists of used devices that have been placed with customers previously & since returned, it would seem likely these can be considered to have already been placed on the market under MDD, and therefore not subject to MDR. You may, however, also wish to consult NB-MED/2.1/Rec5, if you refurbish the rental devices between customers.

Cheers, MB
 

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