Hi Kevin, I stumbled upon this thread while searching for some similar answers. I was wondering if I could get your opinion on this. We can use the same example as OP-
We have an optional Third Party Barcode Scanner (not required for basic functionality of the instrument) that we recommend the Users to get if they want quicker Barcode Reads and Data entry. Would this be an "Accessory" per IVDR? If we consider the definition -
Specifically, Article 2(4) established that 'accessory for an in vitro diagnostic medical device' means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic 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 in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).
My interpretation is - Since our Scanner is Third-Party (we are not the manufacturer, Users can buy it from any vendor using the catalog number), its intended use is decided by its manufacturer which is "to be used to scan barcodes". They do not intend it to be used with any "Particular" IVDMD (such as ours) or to "Specifically" assist the "Medical" functionality of our IVD.
Hence, the scanner is not an "Accessory" per the definition under IVDR.
Let me know your thoughts. Also, if it is not an accessory is it okay if use the term "Auxiliary (Optional) Equipment" for this in the Technical File.
Let me know your thoughts.
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Aashrey Kaul
Sr. Regulatory Affairs Specialist
Irvine CA
United States
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Original Message:
Sent: 22-Mar-2023 13:49
From: Kevin Randall
Subject: IVD Instrument Accessory
Per Europe's IVDR, the definition of accessory for an in vitro diagnostic device' [Article 2(4)] is definitely not invoked when the potential accessory (e.g., a barcode scanner) is an optional add-on module or peripheral. Nor is the 'accessory' category triggered when the potential accessory is not essential to the basic functionality of the class A IVD instrument. And conversely, nor is the accessory categorization nullified if the accessory is necessary for the IVD's basic operation. Instead, it is the opposite.
Specifically, Article 2(4) established that 'accessory for an in vitro diagnostic medical device' means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic 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 in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).
Accordingly, if your intended purpose [i.e., Article 2(12), i.e., your labeled purpose] is that the barcode scanner function in accordance with the Article 2(4) parameters, then it's an accessory to the IVD. You should stick closely to the Article 2(4) definition rather than alternative definitions.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 22-Mar-2023 13:19
From: Rajeswari Devanathan
Subject: IVD Instrument Accessory
Hi,
It depends on how the barcode scanner is integrated into the class A IVD instrument.
If the barcode scanner is an optional add-on module or peripheral that is not essential to the basic functionality of the class A IVD instrument, then it would be considered an accessory.
However, if the barcode scanner is an integral part of the class A IVD instrument and is necessary for its basic operation, then it would not be considered an accessory.
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
Original Message:
Sent: 22-Mar-2023 12:11
From: Anonymous Member
Subject: IVD Instrument Accessory
This message was posted by a user wishing to remain anonymous
Hi everyone,
Is a barcode scanner attached to class A IVD instrument an accessory? I personally see it is not but few of my colleagues disagree with this.
Would appreciate your thoughts on this.
Thanks.