April 14, 2023
EU MDR Accessories: Identification in the IFU
In general, for any class of EU MDR device, but especially for a class III device, the IFU must identify any accessories. Specifically, GSPR 23.4(f) requires (among other things) that, where applicable, the IFU shall contain information allowing the healthcare professional to select the corresponding accessories.
Now, if there really are true accessories for the parent device, then GSPR 23.4(f) will generally always be applicable. I say “true accessories” because we need to be sure that we verify true applicability based on the fundamental meaning of “accessory” from its Article 2(2) definition, which establishes that accessories are intrinsically mandatory or medically-necessary for the parent device’s intended use or medical functioning. In other words, if a proposed accessory isn’t really mandatory or medically-necessary for the parent device, then the proposed accessory is not a true accessory, and thus wouldn’t need to be identified in the IFU. Nor would such an article be subject to the EU MDR’s various other requirements for accessories, though it might still trigger certain other EU MDR categorizations and requirements.
Another piece that needs to be properly considered is precisely how true accessories are described in the IFU. For example, if there’s only one specific brand of accessory that will work with the parent device, then that branded accessory would need to be identified by name in the parent device’s IFU. If there are only two, or some other limited number of accessory brands that will work, then they all need to be named, and so on.
On the other hand, if it is known via valid scientific evidence that the parent device only needs a certain generic type of accessory, or just an accessory with certain general technological attributes, wherefore brand specification isn’t necessary, then naming such accessories by brand might not be needed in the IFU. But this approach could be difficult, if not impossible, to safely realize for higher risk devices like class III; and perhaps also even for any class of device. Indeed, different regulatory authorities may have different habits/tolerances/expectations for such generalized accessory references, and each technology can raise its own unique questions. So, you’ll need to be sure you are in alignment with any such nuances if you choose a generalized accessory reference that doesn’t mention a specific accessory(s) by brand name.
Whatever level of accessory identification you choose, it must be commensurate with the parent device’s risk and complexity. In other words, appropriate corresponding risk control needs to appear in the parent device’s risk analysis in support of the chosen accessory identification approach.
Follow-up thoughts April 15, 2023:
In my narrative above, I only paraphrased the Article 2(2) definition. Per that definition, an ‘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).
But oftentimes, I instead see medical device companies use the word “accessory” in common language terms rather than with strict adherence to the Article 2(2) definition. Accordingly, my approach is that any article meeting the Article 2(2) definition is a true (legislative) accessory. Any article that does not meet the Article 2(2) definition is something else.