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Joined: Feb 2006
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OP
Newbie
Joined: Feb 2006
Posts: 4 |
Hi all,
I am sorry if any offence has been caused, i was just trying to gain feedback/answers from what is considered the best place, the EBME community. I must re-itterate that malice or "bad mouthing" was certainly not my intention and if the question is read again i am sure you will agree. As previously stated, i was just asking for help.
MRJ
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Joined: Mar 2001
Posts: 208
Master
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I have in my hands an Alaris GP volumetric pump, deliver last Friday, and I can confirm that there is a CE mark on the label on the right hand side of pump.
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Joined: Oct 2005
Posts: 49
Technologist
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Technologist
Joined: Oct 2005
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Have to say I have just been on the alaris website and this is what I found. e-Catalog search results 7000C Signature EditionĀ® GP Single Channel Pump. Designed for general purpose infusions. Please note: These products are only available in the USA and Canada. http://www.alarismed.com/na/products/search_results.asp This is maybe old data, but we have also had a look at the new gp and was told they are not ce marked yet. (that was by their own reps)
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Personally speaking if I found it were not CE-marked or that the documentation indicated it wasn't then I'd ask the Cardinal medical/Alaris regulatory affairs people to provide evidence that it is, e.g. provide a copy of certificate of conformance, etc, contact the MHRA for advice and to let them know I had issues with the product markings, documentation or both.
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Joined: Oct 2005
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Technologist
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They dont need a CE mark to show you something they do to sell it.
It may be that the CE mark is pending and the MHRA can clarify if this is the case.
Billy
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Billy, If you actually read my initial "long" posting, previously, then: As an aside and as far as I'm aware (according to the Medical Device Directive 93/42/EEC, i.e. European legislation) no medical device should be put into service without the CE mark but it can be shown at trade fairs, exhibitions or demonstrations without CE marking - but only if appropriate markings indicating that it cannot be sold or be put into use are affixed. Irrespective of the lack of a CE mark I think the device manufacture will have to meet Annex 1, or the essential requirements of MDD 93/42/EEC, at least. To pass relevant information I find more words need to be used - why do you feel the need to repeat what's already been stated (as a colleague of mine pointed out to me)?
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Joined: Oct 2005
Posts: 49
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Technologist
Joined: Oct 2005
Posts: 49 |
Hi Richard
Probably because I havent the time to read all the long postings as I only have an hour for dinner!!
Billy
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Joined: Jul 2002
Posts: 2,020
Hero
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Hero
Joined: Jul 2002
Posts: 2,020 |
Prior to purchase when comparing products you could always get the companies to fill in a Pre Purchase Questionaire, PPQ. One of the questions asks if the equipment is CE marked. There is your answer from the company in black and white. No looking at websites, listening to rumours, hearsay etc. Robert
My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
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Don't think MDD 93/42/EEC is a rumour but I totally agree - however we've received medical devices (audiology application) where the PPQ has stated CE when in fact it's non-CE, in fact non-medical, intended for research purposes. I tend to rely on the CE mark and the official documentation, these days, when dealing with products or suppliers I'm not familiar with. Do you think the information I post is generally incorrect or unreliable Rojo? I try to ensure what I'm going to post is accurate before I post it - but most of the time it's off the cuff/top of my head so it's possible there's mistakes.
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Joined: Jul 2002
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Hero
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Hero
Joined: Jul 2002
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Richard, I admit I posted this without reading the "war and peace" above. I generally find your posts accurate and informative, though sometimes long, but nothing wrong with that if the contents are worth reading. All I was saying is why are people wasting time looking in odd places, speculating and debating whether something is CE marked, when there is an official form that will tell you. Robert
My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
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