One CE Mark holder - multiple manufacturing sites

[keclu]

Dear colleagues,

I work in a company which has affiliates all across Europe, and every affiliate produces the same product. Is it legally possible that the headquarters is the "CE" mark holder, and affiliates are manufacturing sites.

I think that this is possible, and in that case there should be:

- one technical file which describes the product
- one clinical evaluation, one IFU etc.

Every affiliate should comply to MDR as an manufacturer and the headquarters should also comply to MDR.

Is this model somewhere described where I can read something about this?

Thanks…

 

[shimonv]

Each of your affiliates is a critical supplier for manufacturing, and you as the head-office need to supervise, control, and synchronise all of the manufacturing activities. This is more of a QA headache than regulatory issue.

Shimon

 

[yodon]

Just to add to the pain that @shimonv mentions, your auditing organization will likely want to visit each site. Even if they're holding a 13485 cert from an accredited registrar, they'll likely be on the unannounced audit schedule. This could get quite costly.

 

[monoj mon]

Is it legally possible that the headquarters is the "CE" mark holder, and affiliates are manufacturing sites.

Yes it is possible.

I think that this is possible, and in that case there should be:

- one technical file which describes the product
- one clinical evaluation, one IFU etc.

Yes, correct.

Is this model somewhere described where I can read something about this?

My organization fits exactly with your description. We have one HQ in a country but manufacturing sites across different countries where we manufacture the same products. We maintain single technical documentation in our HQ but get audited yearly at each of our sites. Our EC certificate then states HQ as the CE holder and includes the manufacturing sites in different countries.