March 22, 2023

EU IVDR Accessory Definition Triggered for an Optional Item?

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 if the potential accessory isn’t essential to the basic functionality of a 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) establishes 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 potential accessory is to 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.