Can we be our own EU authorised representative?

#21
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
Yes, if you have an office within the EU, this office can be your EU REP according to article 11 and 12 MDR.
 
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Ronen E

Problem Solver
Staff member
Moderator
#22
Yes, if you have an office within the EU, this office can be your EU REP according to article 11 and 12 MDR.
But if the org has an EU-based office ("a registered place of business within the EU") they're not required to have an EU rep. It can be done that way, but it's not required.
 

Ioko

Starting to get Involved
#23
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.
Hi Mounir,

Do you know if under the MDD the EC-Rep must have a Regulatory person? Is there any regulation defining the qualification of the EC-Rep under the MDD only?
If the EC-Rep is the subsidiary (GmbH) of a Non-EU manufacturer, can an employee of the manufacturer works also for the subsidiary and be in charge of the compliance?

Thank you very much
 

Ronen E

Problem Solver
Staff member
Moderator
#24
Do you know if under the MDD the EC-Rep must have a Regulatory person?
No. The PRRC requirement (applicable to ARs too) is newly introduced by the MDR.
Is there any regulation defining the qualification of the EC-Rep under the MDD only?
Refer to the MDD Article 14 s. 2. Other than that the Authorised Representative requirements are scattered - just search the MDD for "Authorised Representative".
If the EC-Rep is the subsidiary (GmbH) of a Non-EU manufacturer
If the Non-EU manufacturer has an EU subsidiary (GmbH), that subsidiary may be considered as the manufacturer itself, in which case no Authorised Representative is required.
can an employee of the manufacturer works also for the subsidiary and be in charge of the compliance?
Certainly.
 

Ioko

Starting to get Involved
#25
No. The PRRC requirement (applicable to ARs too) is newly introduced by the MDR.

Refer to the MDD Article 14 s. 2. Other than that the Authorised Representative requirements are scattered - just search the MDD for "Authorised Representative".

If the Non-EU manufacturer has an EU subsidiary (GmbH), that subsidiary may be considered as the manufacturer itself, in which case no Authorised Representative is required.

Certainly.
Hi Ronen,
Thank you for your answer, it is really helpful. Just to check if I understood correctly: If the subsidiary (GmbH) does not have a person (internally) with a regulatory/compliance background (only business) and contract/hires one of the manufacturer's employee (the employee will work for the manufacturer and the subsidiary), then the GmbH can be the EC-Rep? Of course all of this is only in the context of the MDD and if the subsidiary is not considered as the manufacturer itself.

Thank you for your help.
 

Ronen E

Problem Solver
Staff member
Moderator
#26
Hi Ronen,
Thank you for your answer, it is really helpful. Just to check if I understood correctly: If the subsidiary (GmbH) does not have a person (internally) with a regulatory/compliance background (only business) and contract/hires one of the manufacturer's employee (the employee will work for the manufacturer and the subsidiary), then the GmbH can be the EC-Rep? Of course all of this is only in the context of the MDD and if the subsidiary is not considered as the manufacturer itself.

Thank you for your help.
In the context of the MDD and where the subsidiary is not considered as the manufacturer itself, it can be the EC-Rep and is not required to contract/hire a person with a regulatory/compliance background.
 

Mikilk

Involved In Discussions
#27
In the context of the MDD and where the subsidiary is not considered as the manufacturer itself, it can be the EC-Rep and is not required to contract/hire a person with a regulatory/compliance background.
Please note that the German authorities expect to have someone in Germany to handle local registration, the local rep should be registered in DIMDI and the relevant competent authority (there are few in Germany) then the manufacturer & products should be registered as well. the German authorities require to have local Safety Officer, so it cannot be just a virtual company
 

Ioko

Starting to get Involved
#29
Please note that the German authorities expect to have someone in Germany to handle local registration, the local rep should be registered in DIMDI and the relevant competent authority (there are few in Germany) then the manufacturer & products should be registered as well. the German authorities require to have local Safety Officer, so it cannot be just a virtual company
Hi Mikilk,
If I understood, the Safety Officer does not have to be in Europe right?
Thank you for your help
 

Ronen E

Problem Solver
Staff member
Moderator
#30
Hi Mikilk,
If I understood, the Safety Officer does not have to be in Europe right?
Thank you for your help
Don't confuse the German-legislation-specific Safety Officer with the MDR's PRRC. These are different things. The former is required to be a local employee as far as I remember.
 
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