Dear all,
thank you for your insights. It has been very helpful!
To address some of your questions/remarks:
MAN, AR, IMP, and LH being under one QMS is well established practice in our company for a couple of years now and was successfully audited by our Notified Body.
When I was talking about delegation of responsibility, I was thinking in the lines of the RACI model (at least my understanding of it). The IMP being accountable and LH being responsible for the actual doing. I didn't think about a slightly different meaning of 'responsible' acc. to MDR.
What I learned:
- We will be very careful while wording the contract/QA between IMP and LH.
- We will also implement sufficient surveillance measures/'supplier control'.
Thanks again everyone! If we will need further help in setting this up, I will reach out.
Best,
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Britta Cyron
Senior Specialist Regulatory Affairs
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Original Message:
Sent: 21-Jan-2024 13:02
From: Ludger Moeller
Subject: EU importer responsibility delegation
Dear Britta,
Congratulation on this solution.
Here is your question I believe needs the answer: "We are thinking about setting up a contract between IMP and LH to delegate some responsibilities from IMP to LH.
Do you think this is feasible and are there some caveats or responsibilities we cannot delegate?"
Responsibility cannot be delegated, but certainly tasks may be delegated. I guess that would be the input to an agreement or the level of control excised between entities where an entity being responsible likes to have another entity perform certain tasks on its behalf.
You most likely had this right anyway and the question just needed to be rephrased exchanging the term responsibility with tasks and then the answer would be simply be: YES, and there are no tasks which cannot be delegated.
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
Original Message:
Sent: 19-Jan-2024 03:25
From: Britta Cyron
Subject: EU importer responsibility delegation
Dear all,
we are company (MAN) outside the EU and therefore we need and have an Authorized Representative (AR) and an Importer (IMP). Additionally, we have a Logistics Hub (LH). AR and IMP are the same entity, a daughter of the MAN. LH is another daughter of the MAN. All entities share the same QM-System.
The devices are delivered directly to the LH. LH and IMP are not in the same location. Thus, some IMP responsibilities are difficult to maintain (i.e. checking the actual goods). We do not want to switch complete IMP responsibilities to LH, for various reasons.
We are thinking about setting up a contract between IMP and LH to delegate some responsibilities from IMP to LH.
Do you think this is feasible and are there some caveats or responsibilities we cannot delegate?
Thank you for your insights!
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Britta Cyron
Senior Specialist Regulatory Affairs
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