All - I just find an article that some of you may find to be beneficial.
Thanks for the link to the article (but to be honest, i find it much more confusing than beneficial).
I disagree with the article in many points:
I do not agree with the author regarding the "modules".
I think, he did not get the point.
First, a modular approach is not a must, but a (very) nice to have.
Second, imagine a manufacturer, which provides a Hospital Information System, which has also some functions which have to be qualified as a medical device: in this case he must qualify the whole HIS as medical device (and fulfill all the MDD requirements for the whole system). And the even bigger problem hits the operator of a hospital, which would have to operate this HIS as a medical device.
And third, following the modular approach, one can reduce the CE marking to the relevant medical device modules (there is no need to apply the MDD to any administrative function of a bigger software system).
(Yes, I am participant in a working group on this draft, and I was one of the initiators, who suggested the modular approach, since it would be of great help for manufacturers and health care facilities)
I am also not sure, if the author has read Article 2 of the MDD ("placing on the market" and "putting into service") ot the definition of these terms in the MDD, because I cannot follow his confusion:
Article 2, MDD reads:
Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.
"Placing on the market" is defined as
the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
There is no need of a physical transfer of a device (it is the legal act of the transfer of a product to an other physical or legal person, which counts), and I do not really see a need to distinguish between physical and virtual devices.
"Putting int service"
means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.
This is more or less relevant, if a medical device is put into service without placing it on the market (in case of an in-house production).
Yes, web-services are a "hot topic", but the current draft is a very toned down version (the first draft made almost every software in health care to a medical device). IN all other cases, the MDD has to be applied before placing a device on the market.
Anyone who wants to read the current draft on stand alone software classification can send me a PM (pls include your email address).
And finally I totally disagree with his "It will lead to many unhappy doctors needing to CE mark their websites"...
Yes, there are more and more of apps available in the apple or android market, which should be qualified as medical devices, but the MDD is still a requirement which has to be fulfilled by the manufacturer and not by any intermediaries.
.oO(just my 0.02 €)