Hi Chris. Heres a twopence worth.....
You asked: <what are our regulatory responsibilities vs. those of the distributor? > Whoever places the stuff 'on the market' in the EEA must take responsibility for CE marking. Software doesn't have any directives to follow, but it's packaging does. Mustn't be poisonous, have sharp edges, give off gas etc. etc. Any hardware must, I suspect, comply with the requirements of the Medical Devices Directive. IEC601 is the relevant standard. <Need we simply ensure the "components" of our system ....> If these products are sold in cardboard boxes as individual self-contained units which can be assembled into a multitude of different arrangements, then you should CE mark each component. If however these units CANNOT do anything useful on their own and necessarily require another unit to do anything at all, then they should be CE marked as a system, or sub-system. If your systems are sold in boxes but invariably end up as what could be described as a fairly common or 'standard' setup, then you should CE mark the system. This gives you a few logistical problems as the purpose of the CE mark is to allow free passage of goods across borders, and has no purpose at all in qualifying the 'quality' of the goods. CE marking od 'components' isn't strictly legal, though your unlikely to go to jail over it. < Is software typically CE marked? > The purpose of the CE mark is to allow free trade within Europe. The only thing relevant here is the type of packaging and the actual medium etc., which mustn't be painted in lead based paint, mustn't spontaneously burst into flame, etc. etc. If you shipped your s/w via the Internet, what do you CE mark? < are we still considered the "manufacturer" under the medical device directive?> You are the 'manufacturer' of the bits you supply. The person who actually puts the system together as a functional entity in the EEA is the person who carries the can. Either he carries out the CE qualification exercise, or gets you to supply the stuff already qualified. This is a commercial arrangement twixt you and he. There has to be somebody for the regulatory authorities to terrify, and if you are off shore Europe they can't reach you, so it's the local supplier or the end user who must ensure that the equipment is CE marked. <<If the distributor places their name on the product, (and assumes all responsibilities except design) do they become the "manufacturer"?> Yes, as far as the regulatory authorities are concerned. The active term is 'placing on the market', or for a system made in house or put together from a plurality of parts, the person who 'puts into service' the end system. The Regulatory authorities use the 'last person to touch it' principle, though a seemingly valid certificate and CE mark is a good defence (due diligence). There is a natural justice at work here, if you supply something into the EEA which causes someone to fall foul of the Regs, then they are unlikely to buy any more of your equipment, and will go to a competitor. Or they won't pay you!!! :-) Chris Dupres Surrey, UK. --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
