Service and after care of a Classs IIA Medical Device


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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?

Ronen E

Problem Solver
Re: Service and after care


EU: I think that there's no regulation that creates a service obligation for the manufacturer after the device has expired, provided that the labeling clearly states the device life and instructs how to dispose of it / decommission it (and any applicable waste handling regulations have been complied with, which is not directly related). That's from the MDD perspective - there might be some other applicable generic legal instrument that would establish such obligations (I'd have to research it a bit to say).

US: I'm not sure what else can & should be done. In part it depends on who the users are and what the use environment is. A private, home use is not the same as a hospital use. In the latter case, there might be an authority that might be interested in knowing that a hospital is using an expired device against the manufacturer's instructions; but that's just an educated guess ;)
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Involved In Discussions
Thank you!
So basically we can say that out responsibility as a regulatory department stops when we have deregistered the product in a country, right?
Then other departments such as service etc have to take over?

Does anyone know what is stated in ISO 13485 regarding service?
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