Devices intended to administer medicinal products - MDD 93/43, Annex I, 7.3

[Mike Blanc]

Dear All,

According MDD 93/43, Annex I, 7.3,

"....if the devices are intended to administer medicinal products
they must be designed and manufactured in such a way as to be
compatible with the medicinal products concerned according to the
provisions and restrictions governing these products and that their
performance is maintained in accordance with the intended use."

May I know what kind of testing is need to prove my device is compatible with the medicinal products?

What will be US FDA or Notified Bodies expectations about drug compatibility and stability?

Best regard,

Mike

 

[dgrainger]

Hi, you might want to show that you have looked at the Summary of Product Characteristics (SPC) and patient information leaflet (PIL) for any medicines you may be considering your product to be used with.
e.g. Lipidol states:
6.2 Incompatibilities
Lipiodol Ultra Fluid has been shown to dissolve polystyrene; for this reason disposable syringes made from this material must not be used to administer this preparation

UK info is here: https://www.gov.uk/government/publi...medicines-information-about-specific-products