IMPORTER VIGILANCE ACTIONS

[REGULATED]

Dear friends,

as importers to EU, we have been requested to show that QMS meets with vigilance subject, both MDD and MDR 2017, but my point of view is that the role of importer and distributor must be merely a collector of incidents, potential incidents, suspected devices not to be according to regulation, and also to communicate to customs any action taken by manufacturers and authorities. My reasons are basically lay down in vigilance MEDDEV guide, where there is no a single mention to importers role.

But oppositely is expected us to have a complete classification of incidents, a reporting schedule, a trend reporting basis, and so on. My sincere opinion is that a little importing company has no ability and obligation to take decisions such a withdrawal for example.

So, wich is your experience or your view on this ground?. Wich points should focus a procedure accepting an active role for importing companies?.

Thanks!

 

[NSC25]

I work for a UK manufacturer that uses an EU importer and we did ensure they had a process in place for handling complaints, liaising with competent authorities etc. We took the view as a manufacturer that we needed to ensure our importer were fulfilling their obligations.

While I agree that classification of complaints should be for the manufacturer, Article 13 of MDR has a requirement for importers that
"Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established"

So the question would be how will you decide whether a device represents a serious risk (and then inform your competent authority) if you don't have a procedure for classifying complaints and informing with the authority?

 

[Junn1992]

Please read the MDR carefully and refer to guidance documents here:
Guidance - MDCG endorsed documents and other guidance

 

[REGULATED]

Hi, thanks a lot NSC. You are right, in fact we have a decission tree to discriminate cases to report to manufacturer/authorities, both or none. But seems it is not enough and besides our actions are merely report events we are aware, collect reports, and act accordingly. As importers we do not dare to initiate corrective actions.