Hello Tonia,
There are no regulations which are specific to this situation, however, most regulations deal with the administrative aspect of record retention through the life of the device as you stated. The EU MDR has thankfully clarified this in the regulation which states the record retention starts once the product is taken off the market, i.e. the Declaration of Conformity is cancelled or stopped. Though depending on the device type, the life of the device may continue for a long period of time after. It is not uncommon for capital equipment, instruments, or other durable products to have service and support which extends years beyond when the product was taken off the market. This can even hold true for new models where model 100 was obsolete but is supported for 3 years while model 200 is the new one being sold. A good example is Microsoft Windows where over the years they stop supported Windows 95 then Windows XP and so on.
Sorry to say but customer requirements may be higher in requirements than the regulations. As this can be expected because the customer wants to ensure business continuity or support if the purchasing companies decides not to sell product anymore. Even as a medical device manufacturer we had contracts with our own suppliers to provide five (5) years worth of components if those parts become obsolete or supplier decided not to sell them anymore. This gave us the opportunity to make the proper adjustments or changes over a period of months or years, rather than weeks or sometimes not even being able to provide the product any longer. So to answer your question, this has nothing to do with regulatory requirements, but with customer requirements to ensure they have availability of spare parts or servicing of (assuming) a reusable device.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 30-Jun-2022 02:17
From: Erik Vollebregt
Subject: Regulations RE Service Support/Spare Parts
For which country / jurisdiction? There are no such regulations on EU level but there may be at national level for EU member states.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 29-Jun-2022 15:43
From: Tonia E. Bryant
Subject: Regulations RE Service Support/Spare Parts
Greetings,
So, I have an interesting question...I'm reviewing a contract and the customer wants to stipulate the following:
"Service support and spare parts will be available during the longer of: (i) five (5) years after termination of the agreement by either party or as require by applicable regulations."
I have yet to come across a requirement in the medical device regulations that requires a specific timeframe for service support and spare parts to be offered. I, of course, know about document retention requirements, etc., but this is a new one.
Does any one know of applicable regulations that stipulate timeframe requirements for service support/spare parts?
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Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
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