Hi Anon
It sounds like your product could go either way... If you normally sell the sensors separately and the users normally plug them in, they'd pretty clearly sound like accessories. If you normally build the sensors into the equipment and a service tech would have to swap them, they'd sound more like spare parts.
'accessory for a medical device' means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
Your NB will expect to see a clearly documented rationale for whichever course you choose.
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Anne LeBlanc
United States
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Original Message:
Sent: 19-Aug-2022 10:07
From: Anonymous Member
Subject: Sensors - spare part or accessories?
This message was posted by a user wishing to remain anonymous
Hi
My company manufactures patient monitors and sensor modules. We have several sensors (adapted off the shelf sensors to work specifically with our devices) which plug into our monitors/modules. Should they be treated as a part of the main device or as an accessory?
If treated as a part of the device they won't have to be listed separately on our EC certificate, and if we ever ship them separately (as replacement) they would have to be shipped as a spare part (non CE marked in their own right). However if we choose to call them 'accessories' that changes both the labelling and regulatory approval process.
What is the correct way to deal with sensors in this situation?
Thank you