Can we be our own EU authorised representative?

Cuffern

Starting to get Involved
#1
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
 
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lewisking34

#2
Hi,

I seem to remember reading an IFU from one of the big American eye drop manufacturers, with their EU entity as the EU-AR.
MDD doesn't mention against this scenario so it seems if the EU-AR is genuinely compliant with all the requirements, this scenario should be fine.
 

Cuffern

Starting to get Involved
#3
Hi,

I seem to remember reading an IFU from one of the big American eye drop manufacturers, with their EU entity as the EU-AR.
MDD doesn't mention against this scenario so it seems if the EU-AR is genuinely compliant with all the requirements, this scenario should be fine.
Thanks for that - I think I am fairly certain that the EU subsidiary as the EU-AR would work.

A far easier option for my UK based company (post-Brexit) would be if, by having an EU entity, we don't need an EU-AR at all. It depends on how being a non-EU manufacturer is defined. As we design and develop our device (software only) in the UK - I don't think an EU subsidiary would qualify us as being an EU manufacturer - any idea?
 

moounir

Involved In Discussions
#4
Hi Cuffern,

I confirm that if you have an office in EU then it can play the role of Authorized Representative.
And more than that, this would be the solution I would propose to any company outside of EU if they have the possibility to do that.

This would provide more confidence as you both have the same interest.

The only thing is to be sure to have a person dedicated to Regulatory Affairs, compliance so this office can serve better your needs. If it's only a commercial office without the right person to manage the regulatory parts then it's useless. Then better to choose another AR.

I hope this is helpful. Maybe something for me to clarify on my article on the European Authorized Representative.
 

chris1price

Trusted Information Resource
#5
As Moounir said, using the EU office of your company is a good solution. Don't forget, in addition to a regulatory person, you still need the necessary agreements and responsibilities in place between the companies.
 

Cuffern

Starting to get Involved
#6
Hi Cuffern,

I confirm that if you have an office in EU then it can play the role of Authorized Representative.
And more than that, this would be the solution I would propose to any company outside of EU if they have the possibility to do that.

This would provide more confidence as you both have the same interest.

The only thing is to be sure to have a person dedicated to Regulatory Affairs, compliance so this office can serve better your needs. If it's only a commercial office without the right person to manage the regulatory parts then it's useless. Then better to choose another AR.

I hope this is helpful. Maybe something for me to clarify on my article on the European Authorized Representative.
Thanks for that - I think this might be a viable solution for us. What I am less clear on is if we need an EU-AR at all. I am not certain on how an 'outside EU manufacturer' is defined or where it is defined. If we have an EU located office - can that qualify as our EU address as an EU-based manufacturer if our software is designed and developed outside the EU? Our device is software only and is downloaded rather than shipped - if that makes any difference?
 

chris1price

Trusted Information Resource
#7
The EU manufacturer is defined in the MDD, Article 1, point 2f as:

‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

In theory, your EU office could be the manufacturer, but you would need to ensure they have all the necessary elements of the quality system in place to meet the conformity assessment route, have all the necessary agreements in place and be suitable for audit by a notified body. This might be more trouble than it is worth; but only you can tell that.
 

moounir

Involved In Discussions
#8
As chris1price mentioned, you can be the EU manufacturer and avoid the use of an EU-AR but do you have the ownership of this product?
You should just be the legal manufacturer of the product in Europe to sell it.

I see also an option to be the virtual manufacturer. As you are both part of the same company then you are able to provide all the information to the authorities.

But as Chris1price said, it's really up to you to define your strategy. An authorized representative will do the same as the legal manufacturer. So maybe you will complicate things by trying to transfer ownership.
 

Cuffern

Starting to get Involved
#9
As chris1price mentioned, you can be the EU manufacturer and avoid the use of an EU-AR but do you have the ownership of this product?
You should just be the legal manufacturer of the product in Europe to sell it.

I see also an option to be the virtual manufacturer As you are both part of the same company then you are able to provide all the information to the authorities.

But as Chris1price said, it's really up to you to define your strategy. An authorized representative will do the same as the legal manufacturer. So maybe you will complicate things by trying to transfer ownership.
Thanks - that's really helpful. I am interested in the idea of how we could use an EU-based office to qualify as an EU-based manufacturer. As we would be creating and owning that office - there is no problem of confidential device information to worry about so it is just the regulatory requirements and logistics.

If we want to use the EU office as the 'Virtual Manufacturer/OBL' to what extent would we need to put a QMS in place do you think? The UK office would be the OEM/supplier so would the EU-office need a full ISO 13485 compliant QMS? I am guessing yes, but very cut down with most of the design and development aspects.

That being the case - it would seem that going the EU-AR route would be the least costly and most straightforward.
 

moounir

Involved In Discussions
#10
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.
 
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