Fjalar
Registered
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!
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!