Can we be our own EU authorised representative?

Mikilk

Involved In Discussions
#31
Hi Mikilk,
If I understood, the Safety Officer does not have to be in Europe right?
Thank you for your help
Ronen is right
the safety officer is a requirement that raised in the GERMAN medical act and has nothing to do with the PRRC.
 
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Ioko

Starting to get Involved
#32
Ronen is right
the safety officer is a requirement that raised in the GERMAN medical act and has nothing to do with the PRRC.
Hi Mikilk,

Yes, I see the difference between the PRRC (MDR) and the Safety Officer (German medical act) but can the safety officer be a person that is not working in Europe? I mean, the person responsible for the first placing on the market (EC-Rep or Importer) hires this person but this person is working outside of Europe.

Thank you
 
#33
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.
The MDCG guidance 'appears' to go against your claim above but based upon the regulations themselves I agree with you. Our Notified Body seems to follow the MDCG guidance stance however that the PRRC for the AR and the Manufacturer cannot be the same and that PRRC for the AR should be within the EU. It seems to me that a single organisation with offices in London and the Netherlands (that are geographically close) could have a PRRC permanently available to them (as the regulations state). If the main office moved all operations to the Netherlands then this second set of PRRC eyes is not required - how does having the person in London or Almelo make any difference? I can see why this might make sense when foreign manufacturers are based in a different timezone but not when they are in the same continent. We are essentially looking for a way to just carry on after Brexit by using our Netherlands subsidiary as the AR whilst using the same PRRC (I can see that outsourcing the PRRC role is a risk by comparison) . After all, we would be the same company and be sharing the same legal culpability as if we were only based in mainland Europe (where we definitely would only need a single PRRC). I think that the MDCG are being rather blinkered in their analysis and does not cover the case when a single organisation is not "Outsourcing" it's AR role. I wonder if there is something more to your statement "your Netherlands office is an integral part of your UK business" and if there is a better narrative or some specific arrangements that makes this stance fully robust.
 
#34
Hello,

Quick question: being a non-EU manufacturer and if we set up a virtual office (for example in Austria), would the Person Responsible for Regulatory Compliance (PRRC) need to be based in the country where the office is set up or can this person be part of the non-EU manufacturer's office?
 

Cuffern

Starting to get Involved
#35
Hi,

We have explored this same question. There is some guidance (sorry I forget where) which suggest that the PRRC for the Authorised Rep needs to be based within the EU. So, essentially you can set up an EU entity and put agreements in place to make them the EU AR - as long as that entity has access to an EU based PRRC.

As to how virtual this can be is an open question. EU ARs are subject to audit so it really depends on how information is kept and how contact to that virtual office is made.
 
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