Can an Authorized Representative also be Distributor?

tebusse

Involved In Discussions
#1
Greetings everyone!

I have a question regarding the authorized representative.

I'm slightly confused on whether or not the authorized representative can also be the distributor of the product?

I have read that the authorized representative is to not be confused with the importer, distributor, etc., but is it possibly for the distributor to play duel roles?

Regards, Tonia
 

somashekar

Staff member
Super Moderator
#2
Re: Authorized Rep also be Distributor?

Greetings everyone!

I have a question regarding the authorized representative.

I'm slightly confused on whether or not the authorized representative can also be the distributor of the product?

I have read that the authorized representative is to not be confused with the importer, distributor, etc., but is it possibly for the distributor to play duel roles?

Regards, Tonia
Dear Tonia...
It is possible, and yes the AR has to have specific skill sets and be qualified to perform the AR role. If your distributor has these, he can be an AR as well.
 

tebusse

Involved In Discussions
#3
Re: Authorized Rep also be Distributor?

Thank you, Somashekar. I was thinking along this particular line, but was unsure if I was correct.
 
R

Ron Boumans

#4
Dear Tebusse,

I agree with somashekar. These roles are different but they can be performed by the same companies / persons. Be aware that for the EU there can only be one authorized representative, but there can be several distributors.

And there is an other trap that needs to be avoided: In my work I sometimes see enthusiastic companies that import and distribute medical devices and have de facto become authorized representatives. But they are not aware of that role and the implications. In that case the devices are put on the market in breach of the legislation.
 
E

Erik Vollebregt

#6
Greetings everyone!

I have a question regarding the authorized representative.

I'm slightly confused on whether or not the authorized representative can also be the distributor of the product?

I have read that the authorized representative is to not be confused with the importer, distributor, etc., but is it possibly for the distributor to play duel roles?

Regards, Tonia
Hi, dual roles are possible but you need to take into account that this complicates the distributor relation significantly because the authorised representative is mentioned on the label of the product. If you have a dispute with the distributor about distribution, they may try to leverage the AR relationship against you. Make sure in any event that the distributor uses a different legal entity for the AR work or at the very very least use different contracts. Keep in mind that under the new MEDDEV for ARs linked to in this discussion the AR has an independent duty to report the manufacturer to the authorities and terminate the contract in some cases. Normally, as a lawyer, I advise against mixing the distribution and AR roles. There are good ARs around and the additional costs are worth the trouble you save in conflicts with distributor.
 
E

Erik Vollebregt

#9
Erik,

Are you able to provide any advise about how to locate a reputable AR?

Regards, Tonia
Hi Tonia,

There are several ways to go about this depending on what you are looking for. I assume that with "reputable" you mean "reliable" and "good at what they do".

In that case you would need to separate the letterbox ARs from the ones that are actually in the business of assisting their clients.

A good place to start is to ask them for representative clients and/or other references. If they can't or won't mention any, they probably don't have any. Try to find one with specific expertise in your company's area or the part of the world that your company comes from, that way they will be more effective. You might also ask other companies in your sector which one they use and what their experiences are. Make sure you challenge them on their regulatory credentials: what is their level of knowledge and experience? How will they ensure that the experts are available to your company when you need them on short notice to deal with something urgent? Some ARs are very thinly staffed and will have problems here.

Check their contract and procedures against the latest MEDDEV on authorised representatives (MEDDEV 2.5/10). See if they have really understood what the authorities want them to do. Check the contract for a precise demarcation of responsibilities between your company and the AR; this is usually in the so called RACI matrix in the back of the contract. If that is lacking, you can expect that they will expect you to do most of the work or make things your problem when you expect them to fix it. If they are unwilling to discuss their contract or taylor the procedures to your needs, be suspicious.

See if you can find background on how their are organized. For example, ARs that are part of bigger regulatory consultancy firms tend to be a safe bet because they will usually not just go bankrupt and cease activities. On the other hand, if you can find small ARs that have been doing only that and have been in business for a long time, that's usually a sign that their are doing well. Usually a good track record also signifies historic contacts with authorities, which is what you would like to see (challenge them on this too).

Also, consider that the AR will have access to a lot of proprietary confidential information. Do you trust the company concerned with it? Have you checked that procedures for security of data?

These are just some of the considerations, but probably the most important ones. I hope this helps!
 

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