March 22, 2023

EU MDR Classification of Accessories – “In Their Own Right”

As noted previously, pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used.  But I received a question wondering whether an accessory’s tangential appearance in the Annex VIII classification rules alongside a parent device means that such accessory isn’t actually classified in its own right.

I interpret “classified in their own right” and “classified separately from the device with which they are used” to mean classified based on their own intrinsic characteristics rather than the parent device’s.  In practice, this means that the classification rules are to be applied to, and stand on their own regarding, accessories. For example, consistent with that, Rule 8 prescribes that, if an accessory is for an active implantable device, then the accessory is class III.  The fact that Class III is also the class given by this rule to the active implantable parent device doesn’t in my humble opinion undermine, or undo, or conflict with, or create an exception to, the Commission’s aforesaid implementing rule requiring that accessories be classified separately from the device with which they are used. The classification rules still stand on their own regarding accessories even if a rule happens to simultaneously address the classification of a parent device and its related accessories.