About Dialysis Medical Device Products Registration

L

LQ. Fanny Lozano

#1
Dear all,

I just wondered if anyone had submitted before a register of medical devices with drug products together in the same document? (For example: Dialysis system (Dialysis equipment, catheters, dialysis solution and disinfectant).
I want to know if it's possible to "gather" medical devices with drug products if they contribute to the same purpose.

Thank you so much for your help!! :tg:
 
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pkost

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#2
Are you referring to combination/bordernline products? Such as a prefilled syringe, or bone graft containing an antibiotic?

Under the EU system it is certainly possible to make these combination products. They fall under either pharmaceutical regulations or the medical device regulations (but never both); to determine which regulation to use you have to consider the intended use and method of action. You may find the meddev guidance useful:

http://ec.europa.eu/health/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf - Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal
substance or an ancillary human blood derivative.

I have also found this document: http://ec.europa.eu/consumers/secto...ber_lists/version1_6_borderline_manual_en.pdf which specifically mentions peritoneal dialysis solutions and classifies them as drugs.

edit: you can of course separate them out and gain approval through two different routes. I would have thought this would be a better approach for you as only the dialysis solution is considered a drug and this is a consumable whereas the equipment is more of a captial purchase
 
Last edited:
L

LQ. Fanny Lozano

#3
Thanks Pkost for your usefull advice!! I'll check the link in order to get to know better this Borderline products.
Best regards! :bigwave:
 
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