MDD_QNA
Involved In Discussions
What are the regulation when it comes to service and after care of a product? We have a MD (classs IIA) with the lifetime of 4000h or 10 years, whichever comes first.
After this period, do we have any obligation to service the product? I would say no, but I have only worked with single use devices before. Can someone point me to regulation, guidance or anything that would help me to handle our service organisation who does not know how to say no to customers
Then we have another situation in US, we did a withdraw of our products on the market in 2013 and asked for the products to be returned. But this has not happened in practice and the product is being used off label. I cannot see that this is even a regulatory matter bc the regulatory has done everything necessary, to deregister the product and withdraw it from the market. What else is there to do?
After this period, do we have any obligation to service the product? I would say no, but I have only worked with single use devices before. Can someone point me to regulation, guidance or anything that would help me to handle our service organisation who does not know how to say no to customers
Then we have another situation in US, we did a withdraw of our products on the market in 2013 and asked for the products to be returned. But this has not happened in practice and the product is being used off label. I cannot see that this is even a regulatory matter bc the regulatory has done everything necessary, to deregister the product and withdraw it from the market. What else is there to do?