Hi all,

We currently have a self-declared CE mark for Europe on an IVD...recently one of our clients in Malaysia has asked us to ship them CE marked product. How does this work in regards to the IFU and it's translations, or in this case, lack of translation for Malaysia? We have a separate DI that we use in the States - would we use that one and not send the fully translated European IFU as it wouldn't be applicable?
And, on another (related) note, can you have an authorized rep outside of Europe? We do have a distributor's agreement with Malaysian client and could list them as our authorized rep in Malaysia but I'm wondering how to go about doing that. Do I need a separate TF for Malaysia or can I somehow incorporate this into the one we currently have? Any help or direction anyone could provide would be very appreciated at this point, as my puzzler is getting sore :)

Thanks!

Amanda

Hi all,

We currently have a self-declared CE mark for Europe on an IVD...recently one of our clients in Malaysia has asked us to ship them CE marked product. How does this work in regards to the IFU and it's translations, or in this case, lack of translation for Malaysia? We have a separate DI that we use in the States - would we use that one and not send the fully translated European IFU as it wouldn't be applicable?
And, on another (related) note, can you have an authorized rep outside of Europe? We do have a distributor's agreement with Malaysian client and could list them as our authorized rep in Malaysia but I'm wondering how to go about doing that. Do I need a separate TF for Malaysia or can I somehow incorporate this into the one we currently have? Any help or direction anyone could provide would be very appreciated at this point, as my puzzler is getting sore :)

Thanks!

Amanda

Hi Amanda, :bigwave:

I'm not sure if you'll find anything applicable to your situation, here is something I found and thought it might contain at least a small nugget for you. http://www.mdss.com/articles/article_2.htm

I hope this helps!

I raised this issue at an NB-MED meeting a year or two ago.

Increasingly product will be manufactured in (say) Thailand for export to (say) Saudi Arabia. If the Saudis accept CE-marked product, it makes sense for the Thais to wish their device to carry the CE mark.


A device can bear the CE mark, even if it is not intended for sale in the EU, but:

1) It must meet all necessary requirements to enable it to be sold in the EU, including bearing appropriate label/symbol information, and carrying at least one European language.

2) If the manufacturer is based outside Europe, an Authorised Representative must be appointed.

3) If the product is subsequently exported back into the EU, the original manufacturer / Authorised Representative will bear responsibility (of course).

(Thus agreements on what happens with the product need to be robust).

Hi all,

We currently have a self-declared CE mark for Europe on an IVD...recently one of our clients in Malaysia has asked us to ship them CE marked product. .........

Thanks!

Amanda

For a country that is on the lower rung of development compared to US or Europe, both the FDA and CE marks are important indicators of acceptance and approval because we can't possibly do better than that.

Hi all,

We currently have a self-declared CE mark for Europe on an IVD...recently one of our clients in Malaysia has asked us to ship them CE marked product. How does this work in regards to the IFU and it's translations, or in this case, lack of translation for Malaysia? We have a separate DI that we use in the States - would we use that one and not send the fully translated European IFU as it wouldn't be applicable?
And, on another (related) note, can you have an authorized rep outside of Europe? We do have a distributor's agreement with Malaysian client and could list them as our authorized rep in Malaysia but I'm wondering how to go about doing that. Do I need a separate TF for Malaysia or can I somehow incorporate this into the one we currently have? Any help or direction anyone could provide would be very appreciated at this point, as my puzzler is getting sore :)

Thanks!

Amanda

Your product already bears a CE mark - you are meeting all requirements defined for it.

Your Malasian client has asked for a CE marked product. It is a client requirement. Meet it. You have such product. Give it to him.

Legal requirements and responsibilities related to the CE mark do not apply outside the EU. So you will not be responsible for your product while in Malasia or anywhere outside EU.

If your product eventually reaches EU, you (your European Representative) are as such responsible. And you already have an Authorised Representative there. No issues.