Authorized (EC) Representative Contract and SOP

#1
Hi, I am looking for some guidance related to ARs. We are a small medical device start up, AIMDD/Class3. I recently joined and our NB has recently asked us for our contract with the AR and also our SOP for controlling the AR.

Is there a requirement for a contract, if so can you please point me to the directive?
I have not seen a SOP for controlling the AR before. Does anyone have some experience they can share?

Thanks.
 
Elsmar Forum Sponsor
#3
the MEDDEV guidelines clearly recommend a contract and in the absence of a contract it would be difficult to articulate what functions your AR undertake on your behalf.

How about having a quality SOP on the control of AR/EC Rep. I had not considered this before. Do other people have SOPs like this in place?
Thanks.
 

somashekar

Staff member
Super Moderator
#4
the MEDDEV guidelines clearly recommend a contract and in the absence of a contract it would be difficult to articulate what functions your AR undertake on your behalf.

How about having a quality SOP on the control of AR/EC Rep. I had not considered this before. Do other people have SOPs like this in place?
Thanks.
We have evaluated and selected the AR based on the ability to perform as an AR. This comes directly from our outsourced process control procedure.
Now this AR has provided us such draft contract which covered all the requirements and this we have established after few discussions with the potential AR as the "AR contractual agreement"....
We work with MDSS ... And I am NOT affiliated with them in any way to make a mention here.
 
#5
Thanks for the feedback so far, much appreciated. Talking this over with our CEO today and he has requested an agreement be in place by Monday......does anyone have a draft they can share which outlines the roles the AR can play?
Thanks,
 

somashekar

Staff member
Super Moderator
#6
I felt it will be helpful to put this extract from the new EU MDR 2017/745 here ..... Thanks

Article 12 : Change of authorised representative
The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:
(a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
(c) the transfer of documents, including confidentiality aspects and property rights;
(d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative
 

Mark Meer

Trusted Information Resource
#7
I don't think it's necessary to have a dedicated SOP dealing with this.

As far as the terms of agreement (contract): have you approached any AR's? Typically they will draft an agreement, which I presume are pretty standard. You can use Annex I of the MEDDEV 2.5/10 link Marcelo previously posted as a checklist to ensure that all the necessary Directive requirements are covered.

I also notice that a sample contract was previously posted by Somashekar in this thread. (though I haven't looked at it...)

MM.
 

Dave-h

Involved In Discussions
#8
A quick question on the requirements for EC Authorised Reps.

I can see in the MEDDEV that they should register with their local Competent Authority, but is there a need for them to have 13485 or to have 93/42 approval from a Notified Body?

Thanks.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
A quick question on the requirements for EC Authorised Reps.

I can see in the MEDDEV that they should register with their local Competent Authority, but is there a need for them to have 13485 or to have 93/42 approval from a Notified Body?

Thanks.
No, there are no such requirements.
 
#10
There is no requirement for an EC REP (AR) to be certified to any QMS standard. See for instance articles 11 and 12 of the MDR. They will have to perform the duties of an AR, and are subject to "surveillance" by the National Competent Authority of the member state where they have their address of business.

Expectation is that quite a few AR's will cease to operate, because of increased liability requirements under the MDR. Make sure to inquire. There is an association of ARs (EC REPS). See eaarmed.org. It is likely that members of that association are more likely to stay with it than those who are not.

From the EAARMED site:
The European Association of Authorised Representatives* (EAAR) was established in 2002 in order to accurately represent organizations that provide European Authorised Representative services to non-European manufacturers of medical devices and in-vitro diagnostic medical devices. Its purpose is also to maintain a dialogue with the European Commission, Competent Authorities, Notified Bodies and other European industry associations about the role of Authorised Representatives in the context of compliance with European medical device regulatory requirements.
EAAR is officially recognized by the European Commission and as such is involved in the political process surrounding medical device CE Marking in Europe.
*EAAR is a European Economic Interest Grouping (EEIG) registered in England under number GE192
 
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