Must all Disposable Medical Devices be DEHP Free for MDR?

T

thenewbiemdr

Hi All :bigwave:,

According to the MDR,

10.4.5 Labelling,

where devices, parts thereof materials used therein as referred to in section 10.4.1 contain substances referred to in points (a) or (b) of section 10.4.1 in a concentration above 0.1% weight by weight (w/w), the presence of those substances shall be labeled on the device itself...

So my question is,
is it compulsory for all disposable devices to be DEHP free?

Pls advice. Thanks :)
 
Top Bottom