Responsibilities of Authorized Representative EU

J

john grijpma

#1
I like to put a question to this forum. The question is about the responsibilities of the EU Authorized Respresentative (AR) for medical products (lifts and beds) Class I and IIa in EU. I will probably get this task shortly. Representing manufacturers from US, Mexico and Signapore.

I have read MEDDEV 2.5/10, which states:
The manufacturer is responsible for his obligations under the Medical Device
Directives, not the authorised representative.

To my opion this is not inline with the current role of the AR:
For new or modified products the AR does a Regulatory Affaires Assessement (RAA) , per EU country, searching for applicable standards (flammability, specific product regulation, etc). After completing this RAA these requirements are sent back to the Manufacturer for development.

In this case the AR determines the technical requirements of the end product, is this correct? What should you propose how to handle in this case? The new AR contract is not yet drafted.
Please let me know.
Regards
John
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Responsibilities Authorized Representative EU

Hello and welcome to posting.

For new or modified products the AR does a Regulatory Affaires Assessement (RAA) , per EU country, searching for applicable standards (flammability, specific product regulation, etc). After completing this RAA these requirements are sent back to the Manufacturer for development.
Where is this taken from?

In the MDD context, the AR has in practicality a very limited role, mostly related to class I devices. If other directives / regulations apply to a certain product, there may be other requirements specified elsewhere.

Cheers,
Ronen.
 
J

john grijpma

#3
Re: Responsibilities Authorized Representative EU

Thanks for your reply.
This is the current process how the AR is operating, he checks if regulations are applicable, there is no RA at the Manufacturer site. For the MDD requirements it is clear for me. What about the other applicable product regulations, Is this an AR role? I.e. determine if Flammability or low voltage directive is applicable? Is the AR held responsible for because he is located in the EU?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Responsibilities Authorized Representative EU

You're welcome.

This is the current process how the AR is operating, he checks if regulations are applicable, there is no RA at the Manufacturer site.
I am referring to applicable regulatory requirements. If a certain entity (say, this AR) is acting in ways that are beyond regulatory requirements, due to contractual obligations with other entities, existing de-facto practices, own established SOPs, commercial considerations or other reasons, that's a separate issue. To be able to make useful comments in the broader context, one has to see the entire picture.

A manufacturer might elect not to employ any RA staff and outsource instead. They might also utilize the same service provider for both formal EC representation and RA handling on their behalf. The scope of the latter role may vary, and the service provider's level of involvement may vary as well. Anyway, these are two separate roles. The MDD does not assign such a role with the AR, therefore, from a regulatory perspective (MDD-only context) it can be this way or another.

For the MDD requirements it is clear for me. What about the other applicable product regulations, Is this an AR role? I.e. determine if Flammability or low voltage directive is applicable? Is the AR held responsible for because he is located in the EU?
It all depends on what other regulations (/directives) apply to the product at stake. It is ultimately the legal manufacturer's (as on the label) responsibility to make that determination, and outsourcing RA handling does not relieve from this responsibility. Once the applicable regulations are identified, it's a simple matter of identifying the clauses that discuss the AR's role (if any). I believe the AR would be held responsible only to the extent that is spelled out in the applicable regulations, however, ways of the court are sometimes mysterious and I'm not a legal practitioner. For more certain answers you'd probably want to look at case history or consult an EC lawyer experienced in this area.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#5
Re: Responsibilities Authorized Representative EU

Thanks for your reply.
This is the current process how the AR is operating, he checks if regulations are applicable, there is no RA at the Manufacturer site. For the MDD requirements it is clear for me. What about the other applicable product regulations, Is this an AR role? I.e. determine if Flammability or low voltage directive is applicable? Is the AR held responsible for because he is located in the EU?
The role of the AR is to represent you quickly in the EU and support your cause based on all the information that you keep providing to the AR timely.
Any other activities about the regulatory by the AR is done for a fee or free being a resource person in the EU.
 

mikinnear

Starting to get Involved
#6
Re: Responsibilities Authorized Representative EU

Has anyone got any information about how this changes or if it changes under the MDR?

Thanks all.

Mike.
 

RobertvanBoxtel

Involved In Discussions
#7
Re: Responsibilities Authorized Representative EU

Oh, it will, drastically. See Article 11 of the MDR. And article 12 if you want to change. Very applicable if you EU AR is now in the UK... Which will no longer be part of the EU-28 per april 2019.
 
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