Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hoping for some feedback from this community regarding field specialists maintaining their own "trunk stock" and how this can be managed under MDR, especially considering the enhanced traceability requirements. 

If a field specialist (manufacturer employee) is taking stock directly from the importer and transporting it to healthcare facilities, what are they considered in the supply chain? And is it sufficient for the importer to track the inventory they have passed to the FS, then for the FS to track which inventory they have delivered to/used at which facilities? 

Can anyone offer some best practices or pointers for best managing this scenario? We had hoped to discontinue the use of trunk stock under MDR, but our marketing team has made it clear this is a no-go from their perspective. 

Hello Anonymous,
In my opinion, the role of the FS is that of the organisation they belong to. The importer has put the product through customs and placed it on the EU market (by definition of importer). If the FS belong to the same organisation of the importer, then the importer is a distributor as well. If the FS belong to a different organisation (e.g. the country affiliate) then their role is that of a distributor. The organisation should have procedure in place to address requirements applicable to their role. The FS will act according to these procedures. The traceability requirements are specified in Article 25: The importer/distributor will need to be able to identify economic operators from whom they have received a device, and economic operators and health care facilities to whom they have supplied a device.  I do not see any special or different requirement applicable to trunk stock as opposed to devices held at the distributor's.

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Andrea Sparti
Head of Regulatory Affairs
Ypsomed AG
Burgdorf
Switzerland
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Original Message:
Sent: 03-May-2021 12:58
From: Anonymous Member
Subject: Trunk Stock - managing MDR requirements

This message was posted by a user wishing to remain anonymous

Hoping for some feedback from this community regarding field specialists maintaining their own "trunk stock" and how this can be managed under MDR, especially considering the enhanced traceability requirements.

If a field specialist (manufacturer employee) is taking stock directly from the importer and transporting it to healthcare facilities, what are they considered in the supply chain? And is it sufficient for the importer to track the inventory they have passed to the FS, then for the FS to track which inventory they have delivered to/used at which facilities?

Can anyone offer some best practices or pointers for best managing this scenario? We had hoped to discontinue the use of trunk stock under MDR, but our marketing team has made it clear this is a no-go from their perspective.