Can we have our CE mark on another Manfacturer's parts ?

[QA-RA Jones]

Hi All:

First of all. I have been getting great feedback from folks on topics I have posted. I truly appreciate all of the help!


My Question this time around is the following:

A 'Manufacturer' (US based) has contacted our company about applying our CE mark to their Class I (non-sterile and non-measuring) parts. Is this doable and how?

[We are also a US 'Manufacturer' of Class I, Class I (sterile), Class I (measuring), and Class IIb with an established Authorized Rep and already sell our parts in the EC with our CE mark applied.]

I am assuming we would have to build and maintain the Tech File for them, and we would have to register the products through our Authorized Rep with the CA... but I am unclear on how labeling and CE transferability would work.

Thanks for any guidance you all can offer!

 

[DannyK]

Re: Our CE mark on another Manfacturer's parts

It is doable.
You will be required to have a technical file and declaration of conformity.
You will be required to have authorized EU rep and the EU rep should register the class I device with the competent authority.
You will be required to maintain procedures for vigilance, recall, etc...

 

[QA-RA Jones]

Re: Our CE mark on another Manfacturer's parts

It is doable.
You will be required to have a technical file and declaration of conformity.
You will be required to have authorized EU rep and the EU rep should register the class I device with the competent authority.
You will be required to maintain procedures for vigilance, recall, etc...

I assumed this much, and we already have this structure in place since we are currently selling our own devices on the market. However, how do we label accordingly to transfer the CE (ie. marketing material, IFU, etc)? Do we identify them as the 'Manufacturer' with our Authorized Rep identified? Or do we still place our name and assume all responsibility for the devices through the contract.

 

[Ronen E]

Re: Our CE mark on another Manfacturer's parts

I think that there's some lack of clarity here.

CE marking is not "transferrable" per-se.

Who is going to be the named manufacturer on the label? If it's them, they will have to have the (compliant) technical documentation on site, issue the DoC, engage with the EC Rep, register in the EC etc. If it's you (OBL scenario), some of your obligations are already fulfilled (e.g. nominating an AR) but you'll have to ensure that you fully comply WRT the other manufacturer's device. CE marking clearance is not a blanket type one.

I think what Danny referred to was the latter scenario.