There is no specific regulations about length of time and managing services of devices after they have been stopped from distributing in the market. This information needs to be defined by your organisation based on the risk of the device and life of the device. When looking at equipment that can be serviced, you should define the life of the device including usable life of device and serviceable life of device. A life of a device could be defined as 5 or 7 years based on components lifetimes. However, the usable life could be 20 years or more if the device is maintained properly. Then a serviceable life could be equivalent to the usable life or a shorter period due to replacement parts not being available or obsoleted. Therefore, when you discontinuing selling a device, the serviceable life period kicks in which needs to be established by your company (related to verification testing). You should document the process for discontinuing including how you are going to be handling complaints, service activities, and reportable events. And yes, you should conduct PMS activities, complaints, servicing, etc., through the serviceable life. At some point at end of serviceable life a notification should be sent to the customer the product will no longer be supported, i.e. Microsoft Windows XP example.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 25-Sep-2019 08:31
From: Anne LeBlanc
Subject: Obsoleting Serviceable Devices
When you say "obsolete", I guess you mean to cease production of new devices? And I guess the devices already distributed will continue in use.
The applicable regulations will be those of the country where the manufacturer is located and the countries where the devices have been distributed.
------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 23-Sep-2019 21:22
From: Anonymous Member
Subject: Obsoleting Serviceable Devices
This message was posted by a user wishing to remain anonymous
Hello All, My company is in the process of obsoleting a servicable medical device and would like to better understand the regulatory requirements around servicing the product and complaint handling? Things such as how long must you accept complaints on the device (assuming through stated life of the product) and how long must you service the device (separate of warranty commitments.
Any references or guidance would be very helpful. Thank you in advance.