This message was posted by a user wishing to remain anonymous
Hi, We have to know how your product is regulated. Is it regulated as an OTC product? In which case, I assume the user could transfer it to someone else without any regulatory issue. For instance, if I bought a blood pressure monitor at the pharmacy, I am sure I could give it to someone else. However, if your device is to be used by prescription only, then the user should return the device to their doctor. The doctor should then distribute it to a new patient. Right? I have used a heart monitor that is like that. The hospital issues it to the patient. The patient wears it home and over night. The patient then returns the monitor to the clinic. The clinical does whatever it needs to and then re-issues the device to a new patient. All of this is done under the oversight of the doctor/clinic, not the medical device manufacturer.
As far as whether it needs to be serviced in between uses, this depends on how you have designed the product. You can design a product that can stay at a doctors office for a decade and never need service, or you can design one that needs to be maintained every day. It is up to you and based on what is practical and reasonable for your device. There is no part of the code that says you have to service a device between every use. There is no part of the code that says that a patient can't transfer a device to another patient. The code addresses your claims: who can use it, where should it be used, who can prescribe it, who shouldn't use it, when shouldn't it be used?
Original Message:
Sent: 13-Nov-2019 09:15
From: Anonymous Member
Subject: Support of customer to customer transfer
This message was posted by a user wishing to remain anonymous
We are a manufacturer that sells a medical device to a customer which we then support through a subscription plan. If the customer intends to sell or transfer their device to a new customer, are we able to engage the new owner as a customer? Or do we need to return the device, service and ensure functionality to specification and then redistribute? What part or parts of the act does this touch?
Thank you!