Spare parts for discontinued MDD compliant class I medical device

Fjalar

Registered
#1
Hi guys,

I am trying to understand if spare parts/replacement parts are allowed to be supplied to an MDD compliant, discontinued, class I (self-certified) medical device in the EU. The product is not and will not be MDR compliant, and does not fall into Class I Transitional provisions under MDR article 120.
The manufacturer and manufacturing site are based in the EU.

Supply of accessories to that medical device would not be allowed (as they carry a CE marking in compliance with MDD). As the device needs accessories as well to carry out its intended use, it would seem as though the customer wouldn´t be able to use the device, once the accessory/-ies needs replacement, even if spare part replacement is allowed.

I don´t seem to find guidance in the MDD, MDR, MDCG or elsewhere for this situation. I would be grateful if anyone could clarify.
Thanks!
 
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shimonv

Trusted Information Resource
#2
well, spare parts are not medical device or accessories to medical device. Therefore the MDD, MDR, or MDCG won't talk much about it.
Therefore, as I understand it, they are allowed so long as the device under MDD is in the field, and has not reached its end of life, and doesn't have accessories that needs to be replacement.

Shimon
 

dgrainger

Trusted Information Resource
#3
Spare parts are mentioned in MEDDEV2.1/1:

Spare parts supplied for replacement of existing components of a
device, the conformity of which has already been established, are not
medical devices. If spare parts, however, change significantly the
characteristics or performances of a device with regard to its already
established conformity, such spare parts are to be considered as
devices in their own right.
 

Cybel

Involved In Discussions
#4
Hi,
considering the article 23 of MDR, if your spare part falls in article 23, 1. I suppose you can supply it for the lifetime of your MDD device.
Schermata 2021-05-21 alle 16.22.27.png
 

Fjalar

Registered
#5
Thanks all for input. There indeed isn´t much in legislations about spare parts, so some interpretation needs to be done. I would tend to agree with you, that spare parts for the MDD compliant device ought to be allowed during the lifetime of the device.
 
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