Herbal ingredients MDR

Ben S UK

Starting to get Involved
#1
Hi,

Had a quick question on the use of herbal ingredients within a substance based device, under the MDR. No specific herbal ingredient has been identified so this is a bit theoretical.

The MDR doesn't have any specific (explicit) restrictions on the use of herbal ingredients in devices.

Aside from ensuring there is no PIM mode of action, i.e. the herbal ingredient either has a physical mode of action, or is in the product for a secondary benefit (not PIM) such as flavour, are there any watch outs?

I'm mindful there have been rulings on herbals in the borderline guidance which has focused on MoA - Icelandic Moss. But assuming the herb is not PIM, even if it is listed as a Herbal medicine (based on longstanding use) or the herbal monograph, I don't see a fundamental issue with using them.

Wondered if anyone had any thoughts?
 
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