Hello everyone,
this is my first post and I am happy to have found this forum!
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 (EU) recommendation or something similar.
Thank you very much for your comments in advance.
Best regards,
Nick
this is my first post and I am happy to have found this forum!
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 (EU) recommendation or something similar.
Thank you very much for your comments in advance.
Best regards,
Nick