From: Chris Hartzog <[email protected]>
Subject: The regulatory effect of distribution strategies
Hello everyone,
I have been lurking for a long time and this will be my
first post to the group.
I have a question for the group on the effect on
regulatory requirements of product assembly and distribution strategy.
Here's my situation:
My company develops, manufactures, sells and installs
FDA approved medical devices in the US which integrate with hospital
patient monitoring systems to capture and broadcast via a wireless
system patient alarm data. Our system in no way manipulates this data,
but simply passes it on to a pager or GSM cell phone carried by the
caregiver.
The system consists of a proprietary design pager,
custom server and application software, a low power paging transmitter,
an Intel/NT server, modem, Ethernet hub, and other industry standard
hardware. For US distribution all items are purchased, assembled,
configured, tested, etc. directly by our company.
For European sales, an in-country distributor/dealer
will be responsible for purchasing all items themselves except for our
proprietary pager and software. The other items must of course be
purchased and installed according to our specifications.
My questions are:
1. In this scenario where we only ship software and part of the
hardware what are our regulatory responsibilities vs. those of the
distributor?
2. Need we simply ensure the "components" of our system which we
supply to the distributor are CE marked OR should we assemble a complete
representative system as it will be marketed in the EU and perform all
relevant type testing ourselves?
3. If we need only CE mark the components we ship -- Is software
typically CE marked? Where does one look for the essential requirements
for software?
4. If we are only supplying part of the total system (the software
and pager) yet the system design and specifications are ours, are we
still considered the "manufacturer" under the medical device directive?
5. If the distributor places their name on the product, (and
assumes all responsibilities except design) do they become the
"manufacturer"?
Thank you in advance!
Chris Hartzog
Christopher Hartzog
Quality Assurance Engineer
Data Critical Corporation
2733 - 152nd Avenue NE
Redmond, WA USA 98052
Tel: +1 425.882.6068
Fax: +1 425.885.3377
Email: <mailto:[email protected]>
[email protected]
