Hi everybody,
I'm new to the Medical Device CE certification requirements, thank you in advance for your help!
We have a medical device for a smell=test, (4x6 inch card with smell areas, scratchnsniff) ol-factory dysfunction or lossofsmell. Based on what I have seen in MDD, we have a Class I device. Device is not sterilized, not taking any measurements, should be the lowest Class I categorization. We have a local representative in Germany with 35 years of med device experience.
As Class I devices are self-certified, all we have to do is:
1. compile a technical file and design file -which directive would be the appropriate one?
2. demonstrate compliance with the essential requirements. -Is there any other requirements than local rep? Do we need a QMS?
3. sign our own declaration of conformity
4. register with German competent authority to say that we intend to market the device
Am I missing a step? -or are we in CE compliance with these basic steps?
Thanks for your help!
kimmo01
.
I'm new to the Medical Device CE certification requirements, thank you in advance for your help!
We have a medical device for a smell=test, (4x6 inch card with smell areas, scratchnsniff) ol-factory dysfunction or lossofsmell. Based on what I have seen in MDD, we have a Class I device. Device is not sterilized, not taking any measurements, should be the lowest Class I categorization. We have a local representative in Germany with 35 years of med device experience.
As Class I devices are self-certified, all we have to do is:
1. compile a technical file and design file -which directive would be the appropriate one?
2. demonstrate compliance with the essential requirements. -Is there any other requirements than local rep? Do we need a QMS?
3. sign our own declaration of conformity
4. register with German competent authority to say that we intend to market the device
Am I missing a step? -or are we in CE compliance with these basic steps?
Thanks for your help!
kimmo01
.