EBME Forums Forums Maintenance Technical Assistance CE Marking on new Alaris/Cardinal volumetric

Hi all, i need some advice. The new Alaris GP volumetric, does not carry CE marking and this is stated in very small writing on the back of the literature. My question is, should this product be allowed to trial or be entered into tenders?? I thought this was a big no no.
Your help would be gratefully appreciated

Hi,

I think you need to contact the Medicines and Healthcare Products Regulatory Agency (Tel.020 7084 2000 - 9am/5pm - MHRA ) and ask Jim Lefever (Ext.3262) if he can answer your questions. I'd be prepared to make him fully aware of the circumstances, i.e. whether the device is intended to be used for purposes of demonstation, clinical research, clinical validation, whatever, contact details for the people you've been dealing with at Cardinal medical and any clinicians who may have requested the device be brought into their area (if this is the case).

You might also need to consider issues such as loan of equipment, indemnity issues and associated ethics if the device is going to be left in your possession or used in the clinical environment for evaluation/validation purposes - do you have a risk coordinator, EBME department, Supplies (PASA maybe?) or governance people that you can contact to make them aware of your concerns? Either way the MHRA are the competent authority (regulatory body) for medical devices in the UK so you definitely need to check with them.

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.

I wouldn't have thought, personally speaking, that a clinical trial or tender could progress without the issue surrounding a lack of CE marking being resolved. A lack of CE implies, to me, that a medical device cannot be marketed in Europe, thus it should not be used on patients in the UK without some special arrangement being in place. Hopefully Jim Lefever will clarify this. I don't purport to be an expert or authority on this sort of thing so you must seek appropriate advice. However I'd be interested in hearing what the outcome is if that's possible.

I would like to categorically state and bring to the attention of this forum that the device you mention MOST DEFINATELY DOES have a CE Marking. My Trust has just had a tender presentation and are about to go to clinical trials very soon. Not sure where MRJ is coming from with this as it is my understanding that this product has had a CE mark for quite some time. I suggest you also contact a Mr Peter Highmoor (who I believe is the UK technical manager at Cardinal Alaris).

I do think that it is not helpful to place posts without first checking out with a) manufacturer and b) MHRA. I wonder what the motives are here>? It only sends out the wrong message to members.

Looked at profile, real name listed as Robert Jessop, initials appear to be MRJ. Could the M stand for Mark?

I am not making any assumptions but if MRJ could clarify his affliations i.e. Trust or Supplier that would be great.

Just checked the NHS.net contact directory and no M or Robert Jessop listed for any London Trust. Just a Maryam Jessop at the Royal Free. My apologies if you are above board but we have had companies here in the past stirring things.

Malaky,


Have you seen a copy of the declaration of conformity/certificate of conformance from the notified body for this product Malaky? Just that "categorically stating" anything means nothing unless the proof is there in front of you, signed and dated (preferably before any trials or tenders), in my experience.

Under normal circumstances every medical device should be CE marked and should not be used otherwise. But there may be exceptions under certain, carefully controlled, situations. The MHRA should be aware of any clinical investigations, or trials, involving non CE-marked devices thus my advice to MRJ is to contact them and let them confirm this - he'll be informed of how to proceed in any case I would have thought.

If the device is actually CE-marked and the documentation that MRJ refers to is incorrect then I'm sure the MHRA, as the competent authority, can establish this if MRJ is incapable of doing so. I don't think anyone can read anything more into the question until MRJ responds with facts.

Under normal circumstances non CE-marked medical devices should NOT be used in the clinical environment - however there is provision, I believe, under special arrangements between the manufacturer and the MHRA, for non CE-marked devices to be used in clinical investigations, e.g. performance validation or trials. I wonder why Malaky and Bioman are so "touchy" on this "tender" issue?

I would suggest that the most likely reason for the “does not carry CE marking” comment on the product literature, is because you have an early copy of the US literature. (Check the contact details.)

Many company especially US based company will launch products on to the US market first. Sometimes before they are dotted all the `i` and crossed all the `t` on the CE marking paperwork.

I have also know companies not to CE mark products to prevent there sale within the European Union.

If you are concerned first contact the manufacture/distributor and request a copy of the “declaration of conformity”. And if they are unable to produce a copy, contact the MRHA as recommended by Richard.

Chilly

Hi Chilly,

That was what I was thinking but you'd expect the device to be CE-marked even if the documentation indicates not. 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.

However I try not to make assumptions - that's why I suggested the other possibilities since I know this infusion device is a relatively new product in Europe and that people are eager to get their hands on new products. For it to be considered in tenders and trialled/evaluated prior to purchase I expect there'd have to be a certificate of conformity and most likely a notified body number associated with the CE mark.

Otherwise, hypothetically speaking, prospective purchasers involved in tendering or trialling of products that, perhaps, shouldn't have been released onto the market, at that time, could leave themselves wide open to criticism from other device manufacturers, who're involved in the process, I suppose.

Sonia,

Just one final post - should you be releasing this information, related to a tender/trail of a specific manufacturer's product, into the public domain during the process? Personally speaking, if I was involved in a tender involving this product, I'd have kept quiet about it rather than respond to what I think is possibly a malicious posting. I think Huw should just remove these sorts of threads because, invariably, the intial poster never replies or contributes any further - just as in the case of the Therapy Equipment posts a while back.

Hi Richard

The reason why I questioned whether MRJ's first name was Mark because there is a senior person in Codan called Mark Jessop. At no stage did MRJ claim his Trust was tendering for pumps just that whether Alaris should if they were not CE marked.

The scenario is that a Trust may have OJEU'd for infusion pumps, if business was awarded in Alaris favour this would be advertised in OJEU. I wonder if MRJ is who I think he is, he is wondering whether he has grounds to challenge under OJEU rules on fair competition on the grounds that the successfuls bidders equipment is not CE marked.

I hope MRJ proves I am wrong and his query is above board.

"Huw should just remove these sorts of threads because, invariably, the intial poster never replies or contributes any further - just as in the case of the Therapy Equipment posts a while back."

I think Mr R Ling is absolutely right.

When I saw the first thread by MRJ it made me, on reflection, uneccessarily nervous. Having read the responses since I wonder if I was wrong to respond myself. These types of threads are unhelpful unless backed up by evidence in the first instance. We live and learn

S Malaky