July 12, 2021

EU MDR Scope and Applicability of GSPR 10.4.1

I think there is a good possibility that GSPR clause 10.4.1’s reference both to “invasive” and to “come into direct contact with the human body” may just be an ambiguous redundancy in describing invasive devices, as I have a hard time imagining an invasive device that doesn’t somehow directly contact the human body.  In an explanation from BSI, they seem to have interpreted devices that phrase (“invasive and come into direct contact with the human body”) to simply mean invasive devices.

I’ve also noted that the second two sub-bullets of 10.4.1 are aimed at the indirect contact route (specifically, certain permutations of indirect contact), whereas the first sub-bullet is reserved for the direct contact route (based on its mention of “direct contact” with the human body).  Indeed, the European EU MDR authors seem to distinguish between direct contact and indirect contact (as evidenced by the separate dedication to indirect contact in the second two sub-bullets).  I would be surprised if the EU MDR authors were lumping indirectly-invasive or indirect-contacting devices into the first sub-bullet; this is because if they were, then it would seem there would be no need for the second two sub-bullets.

Because it seems that CMR and ED substances could reasonably be of concern regarding any device that directly contacts the human body, I’ve been recommending that non-invasive direct contacting device manufacturers go ahead and complete the chemical review just to be safe unless more definitive direction is available for a particular case.

I’m also sensitive to GSPR 23.4(s) which calls for IFU precautions where appropriate related to the presence of CMR and ED substances and the potential for device materials to cause sensitization or allergic reaction by the patient or user.  Europe’s liberal stance on toxicants such as CMR and ED doesn’t seem to leave room for excluding users from considerations about the risks of CMR and ED substances.  This would seem to further push the GSPR 10.4.1 interpretation toward including non-invasive direct contacting devices.

In any event, I recommend consulting the responsible notified body (if any is involved) to understand its particular interpretation.