EU MDR Perscription product guidance

Ben S UK

Starting to get Involved
#1
Hello,

Is there anything in the MDR or other relevant EU guidelines with regards to prescription medical devices? I've looked and can only find references related to custom made products.

The crux of the question is whether it is possible for a manufacturer to designate formally their device should only be used under instruction from a HCP via precription or other similar process?

My understanding is that from a wider EU freedom of movement of goods pov, this would be difficult to manage unless explicity mandated in a regulation or directive (i.e. medicines directive).

Is there a way a manufacturer can ensure their product is only sold to consumer/patients under HCP supervision - as there is a danger that grey imports and wholesalers and other distrubutors can sell where they please. Can the manufacturer enforce prescription/HCP only for a CE marked medical device?

thanks

ben
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Ben,
I am not aware of means to ensure prescription use for a devcie in the EU other than through Cautions/Warnings in the IFU.
Your agreement with the wholesalers and distributors should be clear about that.
Your risk management should consider the risk and perhaps other means of mitigations.

Shimon
 
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