Article 12 paragraph 4. "
The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking." Article 12 labeling requires you place the CE mark of each of the componenets of the pack on the labeling and you do not add the overall CE mark associated with your company. We put a box on our labeling with a picture of each component and the CE and notified body number beside each picture. No additonal CE marks go on the packaging. If any of the components are medical devices and are not CE marked, or you cannot document adequate compatability of the devices based on their intended use determined by their manufacturer, you can not use article 12, you must revert back to article 11. The classifcation of the pack is determined by the highest class componenet, however you can self declare with a DoC using article 12, unless you sterilize the finished pack. Then you would need an Annex V cert from a notified body to cover your sterilization processes. But even in this case, you still do not put your CE mark on the package.
"Article 12 of the MDD allows an entity-an assembler-that "puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers" and satisfies a few other requirements to market the products without bearing an additional CE marking. According to Article 12, an assembler is not a medical device manufacturer per se, as the CE marking is not associated with them. Rather, the assembler puts together devices that have the CE marking."
Article 12 states that the DoC must state that (1) you have verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and have carried out your operations in accordance with these instructions, (2) that you ahve packaged the procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers and (3) the whole activity is subjected to appropriate methods of internal control and inspection.
THe system attach button doesn't seem to be working, but if you post your email address, I'll email you an example of an Article 12 DoC.
Hope this helps.
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Melinda Harrison RAC
Director, QA/RA
NeoMed, Inc.
Roswell GA
United States
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Original Message:
Sent: 01-15-2013 04:53
From: Franky Dubois
Subject: MDD Article 12
Hello,
is there anybody with experience on the Article 12 of the MDD (Systems and procedure packs) ?
Do you label the system and/or proceudre pack with "CE" ?
Do you have an example of the declaration made for the system and/or procedure pack ?
Thanks,
Franky