Many regulatory agencies have a total life cycle approach to medical devices, including End of Life (EoL) for devices that must be maintained for some period of time. This is more prominent in US and EU especially under the new EU MDR, but FDA definitely expects life cycle management of a device. Is there a specific regulation? Not really, but there are plenty of regulations related to post market surveillance including service of devices. I would not say it is heresy on what people say, however, there are many interpretations of regulations for maintaining life cycle of a device. As Anne mentioned this is established based on risk, usability, serviceable life, serviceable parts, which should all be address in a type of product discontinuation or product servicing (related to EoL) procedure describing activities that must occur. I can state when I am conducting audits of manufacturers with devices that are serviceable this is definitely an area of review. I mentioned in another thread the life cycle management of a device must be clearly defined, i.e. shelf life, usable life, warranty life, marketing life, servicing life, end of servicing life, and all those applicable.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 21-Sep-2019 19:15
From: Anne LeBlanc
Subject: Obligation to Provide Service after End of Life
I would hope the numbers are based on a risk assessment, with knowledge of the robustness of the equipment. It's an interesting question. There are countries that specify a minimum useful lifetime for some kinds of device, or a minimum number of years of parts/service availability after delivery. I'm not aware of any that require a minimum number of years of service after the end of the device's specified usable lifetime.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 20-Sep-2019 13:16
From: Anonymous Member
Subject: Obligation to Provide Service after End of Life
This message was posted by a user wishing to remain anonymous
Hello RegEx,
Are there any regulations in North America, EU, and/or Asia that specify requirements for servicing devices after formally EOLing them? Our service department came up with 5 years for NA/Asia and 7 years for EU, but I would like to know if these numbers are based on regulations, guidelines, hearsay, etc. They could not track down the source of the info.
Thanks!