Hello George,
Just some additional comment to what has already been provided. Try not to think of your product as all these individual components, in the Technical Documentation describe the device as a "system." Because if you think about individual components versus system approach in your example, indeed power supply and power cords are not medical devices. But in fact your device would not be a medical device either without a power supply or power cord because it could not even be used ! The whole system is a medical device because the instrument needs the power supply and power cord in order to operate. Now if your instrument is a portable type of device with batteries as the power source and a power cord in order to recharge the batteries or provide an alternate power source if available, then these become "optional" accessories. However, in my view they are still part of the system. When you have accessories there are products that need to be used with the system in order to function like power cords or optional accessories which are products providing optional functionality like a printer cable to connect to an external printer.
This does not mean you can not track these individual components as part of customer feedback or customer complaint process. What was said already in fact this is a good practice and should be done. As an example, if the power supply or power cord gets damaged, run over, crimped during use, then the customer may need a replacement. This also does not mean the power supply or power cord failed during use, but you can and should track replacement parts to understand if there are any underlying issues. As example, you get many requests for replacement part because analysis maybe shows customers do not like it or use it in a manner not feasible or conducive to the intended purpose. However, in most cases when customers call, its something like, 'The device is no longer powering on.' The device is returned and during investigation found the housing of the power cord is damaged and when replaced the device powers on, with nothing wrong with the actual device itself. You do not need to separate all these components out as medical device or non-medical device. Utilise your customer feedback and complaint handling process to register post market information about your product and then use your quality system analysis methods to investigate and determine failures of components of the system.
As a final comment, most Notified Bodies view devices as much as a "system" as possible. They would not view a power cord as a non-medical device separately. Cables, cords, batteries, wires, connectors, screens, etc., may all be considered by the Notified Body as part of the system. Then within your General Safety and Performance Requirements (GSPR) - Annex I of EU MDR and risk management file, address each of the components, failures, hazards, and effects which can be linked to your PMS data.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Jul-2020 01:57
From: Spyros Drivelos
Subject: EU MDR PMS Requirements for Non-Medical Devices
Hi George,
From my point of you, all of these items are accessories of your medical device.
It's better for you to track them and evaluate them through your risk management system.
If, let's say, your initial risk assessment accepts the risks posed by the use of those accessories, but in PMS you find out that you have a lot of failures or a certain trend, you will have to re-evaluate your risk assessment and you may want to change your accessories.
All these accessories might not be medical devices by themselves, but they contribute to the intended use of your medical device. You should treat them as one.
Hope that helps
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
Original Message:
Sent: 01-Jul-2020 12:49
From: George Tiller
Subject: EU MDR PMS Requirements for Non-Medical Devices
Hello,
I have a few questions.
The first part is are there any potential PMS activities for products that may not be medical devices per MDR? If we successfully convince our NB that certain items are not medical devices (such as power supply, power cords, printer cable, travel case), I presume we would not need to collect PMS data. Is that correct?
My concern is that these items are used with (travel case) or are part of a Class III device (power cords, power supply, printer cable) so I would want us to still track, and manage, what happens if for example the power supply needs to be replaced.
So the second question is, could we potentially track any complaints for these non-medical device products as part of the Class III device's PMS activities?
Please note that our backup if the NB says, "no, they are considered as medical devices," is for us to propose to classify them as Class I and use the appropriate PMS activities (PMS Plan, PSUR Lite, PMCF).
Has anyone had experience with with their NB with regard to classifying certain products as non-medical devices and what were the NB's recommendations?
Thank you for any guidance!
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George Tiller, PhD, PPM
Los Angeles CA
United States
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