Delimitation of responsibilities manufacturer-importer

Vetty007

Involved In Discussions
Hello everyone,

this is my first post and I am happy to have found this forum! Also I am very sorry for doubling the post, which was possible wrong under the CE section.

I have to create a demarcation of the responsibilities of a medical device manufacturer and its importer and, in the foreseeable future, of a dealer as well.

Is there an official template or recommendations as to how detailed this should be?

My approach is to record the individual aspects in the general contract and then to conclude a separate quality agreement in which time specifications / intervals are specified for the individual aspects with, if necessary, a corresponding SOP. The question I am hanging on is how detailed the aspects have to be specified here - at first I only gave the points from Article 13 MDR (General Requirements for the Importer), but then added adjacent aspects and then lost myself in the question of how far the remarks should go.

I would be thus very happy to receive recommendations or even a template or a reference to an official recommendation or something similar.

Thank you very much for your comments in advance!
 

yodon

Leader
Super Moderator
I would certainly welcome other opinions here as I don't know of any official recommendations; this is just my best guess. I would think a Quality Agreement laying out the responsibilities would suffice.
 

Vetty007

Involved In Discussions
Thank you for your comment - I know simpel responsibility matrixes, but this shouldn't be that easy, esp as there is a new MDCG recommendation available, which I attached.

But also with the Quality Agreement I am curious, how much into details I need to go and I would thus also be happy, if someone has a template (or can recommend one) or any other inspriation :)
 

Attachments

  • mdcg_2021-23_Guidance for NB Distributors and Importers.pdf
    639.4 KB · Views: 90
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