In the Medical Device Directive (93/42/EEC) Article 4 paragraph 3 states:
"At trade fairs, exhibitions, demonstrations, etc. Member States shall not
create any obstacles to the showing of devices which do not conform to this
Directive, provided that a visible sign clearly indicates that such a device
cannot be marketed or put into service until they have been made to comply"
I do not know if this same statement is in place in other directives, such
as low voltage, EMC, etc.
However - Common sense would state that one would want to assure that the
device is "risk free" to environment, humans, etc. if one was going to have
the device placed into an operational mode at a trade show. A risk
assessment should be done to assure the device is electrically safe,
compliant with EMI/RFI (especially emissions, unless you want to "blast" out
your competitors next door in booth) basic requirements. I hope this helps!
-----Original Message-----
From: Lyons, Jim [mailto:[email protected]]
Sent: Thursday, March 02, 2000 4:29 PM
To: '[email protected]'
Subject: Demo Units Sent to EU w/o CE ?
Can anyone tell me if there are provisions for sending prototype electrical
equipment to Europe before it has been CE approved? This equipment would
normally be subject to the LVD and EMC directive, and would be used at shows
to demonstrate the equipment. It is possible that attendies at the show
would touch or operate the equipment.
Thanks for any comments or insight.
Jim Lyons
Mgr - Product Compliance
GTECH Corp.
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