Requirements for being an European Representative

[primavesvera]

Hi, fellow members.

We have a company outside the EU and our CEO would like to open an office in the EU to address marketing and sales from there. The actual production, as well as regulatory compliance, is done from outside of the EU. Our devices have the EC certificate and the company hired the European Representative.

After a short description, my question is: would it be possible to add a person responsible for regulatory compliance to the EU office and avoid having the European representative that way?
I don't know if there are some other requirements to be a rep, other than having the EU place of business and set of competencies laid out in MDR.

I could really use a good answer since CEO is so eager to do this.

Thanks in advance.

Cheers!

 

[KShaw]

Hi Primavesvera!

If the company outside of the EU is to remain as the recognised legal manufacturer of the device, you need to appoint (or in your case, establish) an EU Authorised Representative within the EU such that your labelling / IFU will need to identify an EU AR.

So you can definitely set up an office in the EU and claim that it is your EU AR, however, that office will need to comply with the obligations of an EU AR as laid out in Article 11 of the MDR. This office will also need to appoint a PRRC, who really should be different to the PRRC of the manufacturer.

So you can definitely avoid having to appoint a third-party AR by going through this route. This is commonly done with larger companies that have a presence in the EU.

Hope this helps!

 

[primavesvera]

Hi Primavesvera!

If the company outside of the EU is to remain as the recognised legal manufacturer of the device, you need to appoint (or in your case, establish) an EU Authorised Representative within the EU such that your labelling / IFU will need to identify an EU AR.

So you can definitely set up an office in the EU and claim that it is your EU AR, however, that office will need to comply with the obligations of an EU AR as laid out in Article 11 of the MDR. This office will also need to appoint a PRRC, who really should be different to the PRRC of the manufacturer.

So you can definitely avoid having to appoint a third-party AR by going through this route. This is commonly done with larger companies that have a presence in the EU.

Hope this helps!

Oh, you have no idea how much it helped.
Thanks a lot!

 

[twanmul]

Definitely doable based on the advice above, however you need to ensure that your office acting as the EU Rep will be able to register with the EU Competent Authority and that whomever is acting as the PRRC is aware of any local legislative requirements of the country within which it is established. There are some nuances depending on which EU member state you set up in.