EBME Forums Forums Maintenance Technical Assistance Therapy Eqpt. Diamond Flowmeter

I give up.

Oh, don’t give up. Please.

You are one of the few who writes in with opinions and can back them up.

A.M

"Shouldn’t Medical manufactures have licence (issued by MHRA) to sell the products? If I have to register to be known as a clinical technologist, manufactures register new equipment before it can be called medical equipment."

They have, it's called a CE mark!!!!
As mentioned throughout this thread, the CE mark denotes that the item meets the required standards for selling & marketing the product within the European Community. In other words, it reaches a certain standard of QUALITY.
As mentioned by Robert, it does not guarantee the safety of the product in use.

The CE mark endorses the specific device for sale in the EU not the manufacturer - if the manufacturers quality system/procedures are all that's verified, in all cases, then why not just endorse the manufacturer rather than type-test individual medical products when applicable?

It depends on the annex(s) that apply in the MDD what "standards" are expected of the manufacturer and their products - as I've said It's sort of a sliding scale, the higher the risk classification of the device, by virtue of what it does and how it does it, the more safeguards are built-in to protect the consumer.

At one extreme the manufacturer declares conformity based on the type of device being developed presenting a low-risk and at the other a certificate of conformity may only be issued by a notified body after a range of checks on design, manufacture, production, quality processes and samples of the product are tested, i.e. type-testing.

For example, the full quality assurance route in the MDD, under annex II, the manufacturer has to demonstrate that the specific design, manufacture and quality processes are in place for that product. In all cases, as far as I'm aware, there's a requirement for manufacturers to demonstrate good practice by following the relevant "standards" where necessary. Usually this is easier achieved through following existing manufacturing BE/EN/ISO, harmonised where possible, standards.

We expect this minimum standards of all medical electrical devices all of the time don't we? We look for conformance with every time a new item (with the CE mark) arrives at acceptance, eh? Why do you think most manufacturers tend to comply? Perhaps it's because there are systems of regulation and legislation in place - the regulatory framework surrounding CE perhaps - that expect it as well.

For relatively low-risk devices you may have a point, since there's more reliance on the manufacturer to classify the risk of a product properly thus apply the correct processes to obtain the CE mark for it. But for low risk devices, if they're crap, then when they fail or don't perform properly the threat to patients and users should be relatively insignificant. Fewer high-risk devices that are positively unsafe are likely to pass through a test-house are likely to be endorsed with a CE mark than if no system was in place, in my opinion.

Am I grabbing the wrong end of a very big stick?

Going back Geoff quote “For all practical purposes, the CE mark is meaningless and may be disregarded in any discussion vis-à-vis the quality of one device versus another”.

The CE mark is still a question on the PPQ form.

The good thing about the diamond range of flowmeter is the seven-year warranty on the product. If it dose me the standard, send it back to Therapy Equipment.

A.M

No - the whole point about CE is quality assurance but what's included in the necessary checks for this varies with the type of product - in fact I'd like to dwell more on all lower-risk medical devices going through a more rigorous testing regime but this would be prescriptive and might stop innovation and good ideas from smaller manufacturers from breaking into the market because of extra cost implications.

"Quality" means different things to different people. The question is actually "Which British Standard does the Therapy Diamond Range Flowmeter not meet?" Did the product specification purport to meet them in the first place?

Have all the necessary tests RE:CE endorsement been followed. Well it's on the market so I have to assume so. Looks like a good product with decent warranty and service-replacement backup to me - compared to the competitors products that are also CE marked, anyhow.

"The CE mark endorses the specific device for sale in the EU not the manufacturer - if the manufacturers quality system/procedures are all that's verified, in all cases, then why not just endorse the manufacturer rather than type-test individual medical products when applicable?"

Richard, I stand to be corrected, but I have always understood that the CE mark superceded the GMP (Good Manufacturing Process) and is an endorsement that the manufacturer of a device meets all the requirements for the manufacture of that device ie that the correct materials and manufacturing processes are in place and that the instructions for use, labelling etc all meet the requirements laid down by the regulatory body.
As a result a manufacturer is then given a CE mark with a specific 4 digit code which said manufacturer then applies to ALL of its products.
The CE mark does not endorse the product as meeting the clinical specifications required.

No I disagree. As far as my meagre knowledge goes, the number associated with the CE mark is that of the notifed body that assures conformity of the specific device (and by implication the manufacturers design/manufacturing/production, etc, processes surrounding it) when that approach is applicable (according to risk classification of the device). There are other approaches that verify quality systems involved with manufacturing equipment or allow the manufacturer to declare conformity - hence there's not necessarily a number associated with the CE nor type testing involved in all cases.

You are talking about the CE certificate number such as that issued by BSI for Production Quality Assurance, for example, I think (by the way it's a 5-digit code), Kawasaki. Incidentally Therapy equipment has this for its products as far as I'm aware. The number associated with the CE mark on the equipment is actually the notified body number. So the question is which British Standard does the Therapy Equipment fail to meet?