European Authorized Representative - Their Requirements (Class 1 Medical Devices)

ISO 13485 - Medical

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#1
When deciding on a European Authorized Representative what would you be looking for in the company?


Should the European Authorized Representative (Company) have insurance or any protection for performing the role?

Also what is an average fee for a European Authorized Representative, either a yearly fee or a month fee?

Thanks in Advance
 
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somashekar

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Super Moderator
#2
Re: European Authorized Representative_Their Requirements (Class 1 Medical Devices)

The service contract that you sign for the AR services does mention about the insurance requirement. Amongst other things, seek the DIMDI number of the AR. As for the fee, this has to be mutually agreed upon between you and the AR, who will quote for the annual service contract fee based on the information he gathers from you through his company information form.
 

ISO 13485 - Medical

Involved In Discussions
#3
Re: European Authorized Representative_Their Requirements (Class 1 Medical Devices)

The service contract that you sign for the AR services does mention about the insurance requirement. Amongst other things, seek the DIMDI number of the AR. As for the fee, this has to be mutually agreed upon between you and the AR, who will quote for the annual service contract fee based on the information he gathers from you through his company information form.
Thanks for the help, one thing what is the DIMDI Number?
 
A

Alexisss

#4
Re: European Authorized Representative_Their Requirements (Class 1 Medical Devices)

Got any idea of how much will an AR charge per annum ?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hi there,

Apart from looking for a serious and stable company, which is obvious, I wouldn't look for much more than a fair price and a fair attitude in a European rep. As an illustrative parameter, you can simply count the number of pages on the contract...:) Just like with all other shopping - get several quotes to get some feeling for the market, then choose the one that feels right. Assuming your own company's conduct is fair, there's not too much to the EU rep. issue anyway.

If I may quote a nice NB auditor fellow, he said that EU reps are there only for the case that something bad happens and the authotities needed to put their hands on somebody... that's why they are required to have their place of business inside the EU. Whether or not the rep. has insurance or not doesn't really change the big picture, apart from making the service a little more expensive for you. I am not aware of a specific legal requirement for such insurance, but of course it doesn't say that there isn't one in place.

As for thr price - most reps I know charge a one-time annual fee up front. I'm not too updated but a couple of years ago a 1-1.5K Euro PA would be considered fair. Some charge more, some less, but this was the ballpark figure.

Cheers,
Ronen.

When deciding on a European Authorized Representative what would you be looking for in the company?


Should the European Authorized Representative (Company) have insurance or any protection for performing the role?

Also what is an average fee for a European Authorized Representative, either a yearly fee or a month fee?

Thanks in Advance
 

bio_subbu

Super Moderator
#7
Re: European Authorized Representative_Their Requirements (Class 1 Medical Devices)

Thanks for the help, one thing what is the DIMDI Number?
DIMDI (German Institute for Medical Documentation and Information) is a German databank an Information center, constructed by the German Authority. This databank can only be used by Authorized Representatives or by manufacturers that have a registered place of business in the EU and can notify the MDD products as well as IVD products through the internet. The DIMDI databank system is using similar to the Universal Medical Device Nomenclature System (UMDNS), which provides a common basis for device classification.

For further information please see the DIMDI link
 
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