The device will need CE, thus the typical route is a tech file and a DoC.
Refer to the Medical Device Directive (MDD) or the In-Vitro directive. From
the little info you provided I would guess the Medical Directive is the one.
Reading the scope of both should assist you in selecting the appropriate
directive. Annex I in the directive provides the "essential requirements"
you need to be compliant with. You also need to (first thing) classify your
device, article 9 of the MDD will assist here. Article 11 of the MDD
addresses conformity assessment procedure, this identifies which of the
other Annexes you may follow to allow CE marking of the device.
This is somewhat condensed, best advise - obtain the directives, read
through them (more than once is highly recommended) and comprehend the
contents.
Good Luck!
If you wish you can contact me directly with any other questions, I may have
the right answer!
-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Wednesday, January 17, 2001 2:13 AM
To: [email protected]
Subject: Medical devices
Hi all
Can some one give me links to information regarding EU Medical Devices
directive.
My problem is to define the requirement for the following situation:
A manufacturer is making an add-on device for another company's medical
device and the total equipment is CE approved without involving the
manufacturer. Now the manufacturer want to CE mark this add-on device and
sell it to other companies as a CE approved device still for medical
equipment.
What is the requirements for this manufacturer, they have never been into
CE markin before.
The equipment is used in laboratoriums to move small glases with different
materials for testing in another test device.
best regards,
Kim Jensen
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For help, send mail to the list administrators:
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Richard Nute: [email protected]
