Can anyone direct me to the EC rules which govern beta site installations?
For example, what if a contract is signed with the beta site, specifying
that the unit is not yet evaluated, and specifying terms of beta testing and
timeframe. Would that qualify as "under the control of the manufacturer"?
Having your own people run the thing, even at a remote site, rather defeats
the intention of a beta test, and it's a bit hard to believe that this is
how it's really done.
Thanks,
Paul O'Shaughnessy
Affymetrix, Inc.
Lou Guerin wrote:
"For Europe you have less leeway, you can show the product at a trade show
with a PROMINENT label declaring that the product has not been evaluated for
compliance to the appropriate LVD and EMC directives. The directives
prohibit the "placing on the market" or "putting into service" any product
that does not conform to the directives. This only allows you to demonstrate
the product at the customer's site if it is always under the control of the
manufacturer. For a Beta unit, you would need to send one of your people to
operate the equipment until it is returned to your factory or you get
approvals on that configuration."
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