CE Mark Question, Manufactuerer or distributor, steps the same?

[joravetz]

Hi,

I know this is going to sound off the wall. I'm am just looking for clarification to verfiy whether I'm correct or not for my boss. If you are going to obtain a CE for a medical Device Class IIA (I believe, might be B) is it true that the manufacturer must obtain the certification? The distributor of the product would not be able to obtain it.
that's part one

now part two
Regardless of either company (distributor or manufacturer) obtaining the certification, is it true that the same steps would be taken to receive certification, tech file, Authorized Rep. , notified body, etc.

Thank you for any help.

Jina

[Al Rosen]

Originally Posted by joravetz

If you are going to obtain a CE for a medical Device Class IIA (I believe, might be B) is it true that the manufacturer must obtain the certification? The distributor of the product would not be able to obtain it.
that's part one

I don't think a distributor can fulfill the Essential Requirements.

Originally Posted by joravetz

Regardless of either company (distributor or manufacturer) obtaining the certification, is it true that the same steps would be taken to receive certification, tech file, Authorized Rep. , notified body, etc.

I'm not sure what you mean by "same steps", but you need a Technical file, Notified Body and an Authorized Representative along with all the other requirements of the Medical Device Directive.

[joravetz]

Hi,

Thanks for the info, you confirmed what I thought.


Jina