X-RAY Based Diagnostic Veterinary medical Devices

Regulatory

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#1
Hi,
we are manufacturer of class IIb X-Ray based medical devices and having CE marking under MDD 93/42/EEC. now we are thinking about expending our product in veterinary field.. please guide which regulation or directive or standard will applicable for veterinary medical devices for product sale in Europe.


Looking forward for your kind advice..

Thanks in advance..
 
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#2
Hi,

As in Europe the definition of a medical device is only focussing on human use, in general such products are not regulated as medical device. Instead they are falling under other regulations/laws. From my understanding in most of the countries those products are regulated as medicinal product (drug).

I would recommend this article:
raps.org/news-and-articles/news-articles/2018/4/us-and-eu-veterinary-medical-device-regulation

(Sorry I am not able to post it with as a link)

Best regards,
Torsten
 

Regulatory

Involved In Discussions
#3
Hi,

As in Europe the definition of a medical device is only focussing on human use, in general such products are not regulated as medical device. Instead they are falling under other regulations/laws. From my understanding in most of the countries those products are regulated as medicinal product (drug).

I would recommend this article:
raps.org/news-and-articles/news-articles/2018/4/us-and-eu-veterinary-medical-device-regulation

(Sorry I am not able to post it with as a link)

Best regards,
Torsten
thanks a lot for the information..
 
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