Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role. Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question; “Can you trust your importer or distributor with your intellectual property”?
This is an especially critical issue for new and innovative technology. Advena already operates a best practice approach treating client data as confidential, to reinforce this we encourage the use of non-discloser agreements, whereas others such as distributors may not always act in the manufacturers best interests and therefore, may not be so diligent.
When a device manufacturer works with Advena all confidential documents, manuals, certificates, dossiers and project related files are only stored on our secure password protected server that is accessible only to employees who are subject to stringent confidential agreements.
Client confidential data would never be archived on laptop computers that could be lost or stolen.
The new medical device regulation (MDR) stipulates that the manufacturer shall in order to allow its Authorised Representative to fulfil its tasks ensure that the necessary documentation is permanently available. This will be very important in the future where EU Authorised Representatives will be legally required to be able to access manufacturer’s compliance data.
So the question is, do you really want your distributor or importer to have permanent access to your sensitive technical data?
If you currently use a distributor or importer as your EU Authorised Representative, this is a subject worth some serious consideration.