Can we be our own EU authorised representative?

Cuffern

Starting to get Involved
#11
Hi Cuffern,

Happy that it opened more opportunity.

Let's summarize again
Case 1: Your office in Europe is the Virtual Manufacturer
- This office will register the product in Europe as if he is the owner of it. So you'll need to provide all the documents as a Real Manufacturer.
- You should consider the OEM as a supplier of the product that you ordered. Audit of the OEM should be included on your procedures.
- You don't need an EU-AR as the legal entity (virtual manufacturer) is located in Europe
- You need a Notified Body to provide you CE certificate and ISO 13485 certificate. So you need also a QMS
- The OEM/Supplier can be also audited as he will be considered as Critical Supplier.
- You'll need to appoint a PRRC (Person Responsible for Regulatory Compliance)

Case 2: Your office in Europe is acting as EU-AR
- This office needs to register in the European Union as Authorized Representative
- In case this office can be also considered as the importer you can have Importer and EU-AR under the same roof
- You don't need a specific ISO 13485 and CE mark certificate as you are not considered as the manufacturer
- You still need to have a PRRC.

This is not an exhaustive list but these are the major things that I recall.

Then it's up to you to choose the best strategy. Tell me what you think.
Thanks again - that is pretty much how I read it. We had some bland advice from our NB that we only need to open an office in the EU and we will be ok (i.e. no need for an EU-AR) but I think that misses all of the important detail we have been discussing.

We already have an existing CE certificate so in Case 1, I think that would no longer be valid so the new EU virtual manufacturer would need to re-apply for CE marking. Our existing ISO 13485 certification would not be valid either. Getting new certificates is not the end of the world and might be worth it for single-market access - though there are continuity issues to consider.

What I am less sure about for case 1, is what the QMS would look like for the Virtual Manufacturer. Theoretically, could it be a team of one - a PRRC who also doubles up for the rest of the QMS roles? The smallest QMS I have ever worked on had four employees - where the aim in case 1 would be to keep the Virtual Manufacturer as small as possible.

My colleagues are looking at the legal options to see if, by having an EU subsidiary, we can quality as an eu-based manufacturer without the need for a separate Quality certificate and CE Certificate - but I don't see how that is possible. What makes it less clear is that the MDD states that we need a registered place of business in the EU - it doesn't state explicitly that the manufacturer on the label must be the same as the registered place of business in the EU. I am sure this must be defined somewhere - any ideas?
 
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moounir

Involved In Discussions
#12
Thanks again - that is pretty much how I read it. We had some bland advice from our NB that we only need to open an office in the EU and we will be ok (i.e. no need for an EU-AR) but I think that misses all of the important detail we have been discussing.

We already have an existing CE certificate so in Case 1, I think that would no longer be valid so the new EU virtual manufacturer would need to re-apply for CE marking. Our existing ISO 13485 certification would not be valid either. Getting new certificates is not the end of the world and might be worth it for single-market access - though there are continuity issues to consider.

What I am less sure about for case 1, is what the QMS would look like for the Virtual Manufacturer. Theoretically, could it be a team of one - a PRRC who also doubles up for the rest of the QMS roles? The smallest QMS I have ever worked on had four employees - where the aim in case 1 would be to keep the Virtual Manufacturer as small as possible.

My colleagues are looking at the legal options to see if, by having an EU subsidiary, we can quality as an eu-based manufacturer without the need for a separate Quality certificate and CE Certificate - but I don't see how that is possible. What makes it less clear is that the MDD states that we need a registered place of business in the EU - it doesn't state explicitly that the manufacturer on the label must be the same as the registered place of business in the EU. I am sure this must be defined somewhere - any ideas?

For the QMS there is maybe a discussion to have with your Notified Body. You can integrate your EU office under the scope of the QMS. So it means that they will have to follow the same procedures.

What is the advantage?

1- You will not have to recreate a full QMS but only update the one you have by including the additional site
2- You can include on your current certificate a new site. So you'll need to discuss with your NB for that.

But the virtual manufacturer will still need to receive auditors that will check if you are complying with what is mentioned. This office will have a certain role and not all the role of the manufacturer.

Example:
- OEM is the manufacturer and is performing action 1, 2 and 3
- Virtual manufacturer is performing action 4, 5 and 6

So you inform your NB about the responsibility of your office so he will not be audited for everything but only for what he is responsible for. And if the auditor want to audit them for the manufacturing part they'll need to go to the plant outside Europe.

Looks like a good strategy. But as always, discuss with the NB.

On the second point that you mentioned regarding the place of business and the label. This is what is mentioned regarding the economic operator.
It says that the manufacturer should have its place of business in Europe and if not then he needs to appoint an Authorized representative [MDR article 10(8)] didn't check MDD but should be the same as this concept of Authorized Representative exist already.
 

Cuffern

Starting to get Involved
#13
For the QMS there is maybe a discussion to have with your Notified Body. You can integrate your EU office under the scope of the QMS. So it means that they will have to follow the same procedures.

What is the advantage?

1- You will not have to recreate a full QMS but only update the one you have by including the additional site
2- You can include on your current certificate a new site. So you'll need to discuss with your NB for that.

But the virtual manufacturer will still need to receive auditors that will check if you are complying with what is mentioned. This office will have a certain role and not all the role of the manufacturer.

Example:
- OEM is the manufacturer and is performing action 1, 2 and 3
- Virtual manufacturer is performing action 4, 5 and 6

So you inform your NB about the responsibility of your office so he will not be audited for everything but only for what he is responsible for. And if the auditor want to audit them for the manufacturing part they'll need to go to the plant outside Europe.

Looks like a good strategy. But as always, discuss with the NB.

On the second point that you mentioned regarding the place of business and the label. This is what is mentioned regarding the economic operator.
It says that the manufacturer should have its place of business in Europe and if not then he needs to appoint an Authorized representative [MDR article 10(8)] didn't check MDD but should be the same as this concept of Authorized Representative exist already.
Hi, I guess that's where the ambiguity is for me. If we open up an EU place of business - a subsidiary office, is there anyway that that can qualify our company as an EU based manufacturer (based on a combination of two sites) without having to go though the OEM/OBL route? I think probably not - but I am trying to understand if there is some mechanism where that would be possible. My CEO is convinced that it is!
 

Dave-h

Involved In Discussions
#14
Good afternoon, picking-up on this thread from the end of last year.

We are a UK based manufacturer and we are looking to set-up our Netherlands office as our EU Authorized Representative.

Do you know if our Authorized Representative needs to be approved by our NB?

They will be registered with the local CA, but reading the MDD and MDR, I can't anywhere that it says that they should be NB approved.

Any ideas?

Thanks.
 

chris1price

Trusted Information Resource
#15
No, you The AR does not need to be approved by the NB.

There are a lot of new requirements for the AR, take a look at Articles 11 and 15 in particular. However there are requirements throughout the MDR.
 

moounir

Involved In Discussions
#16
Hi,

Does anyone know if a non-eu based manufacturer opens up an office in the EU - does this mean an authorised rep is not needed or, if it is needed, can the EU office be the authorised rep?

Thanks
Hi Dave-h,

No there is no need for your Notified Body to approve it. Your office in the Netherland can be an authorized representative for you but don't forget that you need to have a Person Responsible for Regulatory Compliance PRRC that represents this office.

I hope this is helpful.

Regards.
 

Dave-h

Involved In Discussions
#17
Thank you both for your speedy replies and for your confirmation.

I believe we will have everything in place for Articles 11 and 15 and indeed for the PRRC.

My job now is to write the agreement and to make sure that I cover all of the necessary elements. Have you seen any good examples or a template or a list of the points to address in such an EU REP agreement?

Thank you again.
 

Ronen E

Problem Solver
Staff member
Moderator
#18
Good afternoon, picking-up on this thread from the end of last year.

We are a UK based manufacturer and we are looking to set-up our Netherlands office as our EU Authorized Representative.

Do you know if our Authorized Representative needs to be approved by our NB?

They will be registered with the local CA, but reading the MDD and MDR, I can't anywhere that it says that they should be NB approved.

Any ideas?

Thanks.
If "your Netherlands office" is an integral part of your UK business, you don't need an EC rep and can have a single PRRC for both.
 

Dave-h

Involved In Discussions
#19
Hello Ronan, thank you for your reply.

I was asking the question in preparation for life in a post-Brexit world, in which we will need to have an EU AR that is within the EU.

Thanks,
 

Ronen E

Problem Solver
Staff member
Moderator
#20
Hello Ronan, thank you for your reply.

I was asking the question in preparation for life in a post-Brexit world, in which we will need to have an EU AR that is within the EU.

Thanks,
Brexit (even a no-deal one) doesn't change my answer.
Refer to post #7 in this thread.
 
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