Can a Distributor Apply for Registration of a Product in the EU

Ronen E

Problem Solver
Staff member
Moderator
#11
Thank you. Yes, I did mean "as the distributor", typo. This is good information. What about other international markets like Canada, LAPAC, and Australia. I think Australia may want to have the product CE marked first. Do you have any input on this?
Hi there,

Australia does not require a CE mark. It has its own regulatory system, which is quite similar to the EC one but not identical. It also has a Mutual Recognition Agreement (MRA) with the EC, which can save a lot of the effort, but only if the CE-marked product originates from within the EC, Australia or NZ. A USA-made CE-marked product won't benefit the MRA.

Cheers mate:cool:
Ronen.
 
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pkost

Trusted Information Resource
#12
Hi there,

Australia does not require a CE mark. It has its own regulatory system, which is quite similar to the EC one but not identical. It also has a Mutual Recognition Agreement (MRA) with the EC, which can save a lot of the effort, but only if the CE-marked product originates from within the EC, Australia or NZ. A USA-made CE-marked product won't benefit the MRA.

Cheers mate:cool:
Ronen.
I knew about the MRA, but didn't know that a USA-made CE marked product wouldn't benefit - do you know why? It seems rather odd!
 

Ronen E

Problem Solver
Staff member
Moderator
#13
I knew about the MRA, but didn't know that a USA-made CE marked product wouldn't benefit - do you know why? It seems rather odd!
I don't know for sure, but my guess is that the reason is that this is a MUTUAL recognition agreement. As far as I'm aware, the FDA does not recognize the Australian conformity assessment just yet.
 

pkost

Trusted Information Resource
#14
I don't know for sure, but my guess is that the reason is that this is a MUTUAL recognition agreement. As far as I'm aware, the FDA does not recognize the Australian conformity assessment just yet.
Interesting... but the FDA has nothing to do with CE-marking; do you mean FDA approved via 510k or PMA?
 

Ronen E

Problem Solver
Staff member
Moderator
#16
A product that probably would be MDD Class III but comes from a company that didn't have an ISO 13485 QS during its development and qualification for the US market, and for which MDD requirements were not addressed on a running basis during that development, is pretty much the worst case from the point of view of your company getting all the ducks in a row to market it in the EU.
I would have thought that a class III device legally marketed in the USA (cleared under 510k) would have been subject to a part 820 compliant QS, would have a proper Device Master Record, and probably have a reasonable Design History File. Not a bad starting point for MDD compliance, and in my opinion not a very long way from ISO 13485 compliance de-facto.

I'm sure you know that but still worth mentioning that the MDD does not mandate ISO 13485 compliance; this is just a convenient way of meeting the QS-related requirements.

Cheers,
Ronen.
 
M

MIREGMGR

#17
Regarding Australia and the US FDA, note that FDA is accepting Australia-authorized NB certification of audit reports for an ISO 13485 QS as part of the new Voluntary Audit Report Submission program, which gets a manufacturer out of QSIT1 exposure for a year at a time.

Regarding US FDA not accepting Australian product certification...FDA doesn't accept anybody else's product certification yet, either. I don't think there's any anti-Australia undercurrent.

My understanding is that Australia's determination not to accept US FDA product acceptance/approval as equivalent to CE Mark isn't tit-for-tat. I think it's because FDA's approval processes simply aren't equivalent at present, being tougher in some respects but looser in others.
 
D

drewsky1

#18
The company does comply to ISO 13485. They do not have a notified body as they have never registered any of their products in EU. IIFa company does not have a notified body (NB), it does not necessarily mean they do not comply to ISO 13485. They would only have a CE certificate on a product they registered in EU. Please correct me if I am incorrect.
 

pkost

Trusted Information Resource
#19
I'm not sure of the question, however I will give it a go:

It is not necessary to have a CE mark to be compliant with ISO 13485 however, when applying for a CE mark, if they were to go down the route of claiming they complied with ISO 13485 in order to demonstrate they had a suitable quality management system in place then they would have to be able to demonstrate this i.e. they would have to have an ISO 13485 certificate.

What I am not clear on is how easily they will accept a certificate from another registrar. Obviously they won't accept one signed by your mate bob down the road, but....

However...If you haven't been dissuaded from CE marking the device yourself, then it isn't their quality system the NB will worry about...it will be your quality system and whether the product was designed in a systematic and appropriate manner. As part of your quality system you should have identified suitable manufacturers (i.e the real manufacturer) and determined that they are capable of producing the device to the approved specification whether they do that to ISO 13485 or not
 

Ronen E

Problem Solver
Staff member
Moderator
#20
I don't think there's any anti-Australia undercurrent.

My understanding is that Australia's determination not to accept US FDA product acceptance/approval as equivalent to CE Mark isn't tit-for-tat.
I hope you were not implying I said any of the above, because I didn't.

I do think however that behind the scenes there are some happenings that are not 100% to the point. Some web research on the topic can give an idea.
 
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