alimary15
Involved In Discussions
Good evening to everyone,
My company has developed a flat panel detector to be used for X-ray Imaging. We would like to sell this device but we not sure about what CE marking should be.
The device can have both industrial and medical applications.
For the medical applications, we would like to sell it to a third part manufacturer that, according to Article 12, will assembly it into a medical device system, so being himself responsible to mark the assembled system as a CE MDD.
To my company side, We would like to get a CE marking not as Medical Device avoiding so to go trough a ISO 13485 managment system and all the strict requirements that are asked for MDD.
Flat panel detectors are used a lot also in industrial applications for Imagining purpose. Can anyone help me and give me suggestions on what kind of CE marking (not MDD) is it possible to apply to the detector ?
Thank you so much
My company has developed a flat panel detector to be used for X-ray Imaging. We would like to sell this device but we not sure about what CE marking should be.
The device can have both industrial and medical applications.
For the medical applications, we would like to sell it to a third part manufacturer that, according to Article 12, will assembly it into a medical device system, so being himself responsible to mark the assembled system as a CE MDD.
To my company side, We would like to get a CE marking not as Medical Device avoiding so to go trough a ISO 13485 managment system and all the strict requirements that are asked for MDD.
Flat panel detectors are used a lot also in industrial applications for Imagining purpose. Can anyone help me and give me suggestions on what kind of CE marking (not MDD) is it possible to apply to the detector ?
Thank you so much