Classification of Syringe (nozzle) of needle free injection system.

#1
Hi
I am trying to figure out the classification for the syringe (nozzle) of a needle free injection system - i have come with a class but it was up for discussion within my team. For this reason i needed some clarity on this topic.

Please let me know if you need any more information.

Thanks in advance!
 
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Ronen E

Problem Solver
Moderator
#4
Hi Ronen

Just a difference in understanding of the mechanism of device leading to different classification of the device.
Thanks, but we'll need a bit more detail in order to make a meaningful attempt... If difference in the understanding of the mechanism leads to different classifications, then we'd need to know something about the mechanism - won't we?
 

Philip B

Quite Involved in Discussions
#5
Empty syringes intended for manual administration of a drug to a patient are Class I (sterile / measuring). If they can be used in an automated syringe pump (normally larger sizes, 20ml nominal capacity and greater) they jump up a classification to IIa. If you pre-fill the syringe with drug product yourselves then this is a combination product and might be classed as a medicine not a medical device, sorry not sure. If the syringes are used for mixing products only, or for lab analysis work and don't go anywhere near a patient then they are not medical devices and shouldn't be CE marked. Your Notified Body should be able to advise as well.

Hope this helps.
 
#6
Thanks, but we'll need a bit more detail in order to make a meaningful attempt... If difference in the understanding of the mechanism leads to different classifications, then we'd need to know something about the mechanism - won't we?
We were trying to figure out whether the syringe would be 'Surgically invasive'. Syringes with needle are invasive but the needle free syringe in my opinion is not since. Needle free syringe are used administration with the help of an ejector.
 
#7
Empty syringes intended for manual administration of a drug to a patient are Class I (sterile / measuring). If they can be used in an automated syringe pump (normally larger sizes, 20ml nominal capacity and greater) they jump up a classification to IIa. If you pre-fill the syringe with drug product yourselves then this is a combination product and might be classed as a medicine not a medical device, sorry not sure. If the syringes are used for mixing products only, or for lab analysis work and don't go anywhere near a patient then they are not medical devices and shouldn't be CE marked. Your Notified Body should be able to advise as well.

Hope this helps.
Thanks Philip for your inputs. The syringe is actually used with an ejector.
 

Ronen E

Problem Solver
Moderator
#8
We were trying to figure out whether the syringe would be 'Surgically invasive'. Syringes with needle are invasive but the needle free syringe in my opinion is not since. Needle free syringe are used administration with the help of an ejector.
Surgically invasive means that at least part of the device penetrates into the patient's body, not through a natural body orifice.
Even a conventional syringe with a needle is not surgically invasive unless the needle (or an equivalent element) is an integral part of the syringe. The needle itself is.
 
#9
Surgically invasive means that at least part of the device penetrates into the patient's body, not through a natural body orifice.
Even a conventional syringe with a needle is not surgically invasive unless the needle (or an equivalent element) is an integral part of the syringe. The needle itself is.
Yes that was my argument as well.
 
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