Customer wants customized Software for Medical Device

T

temujin

#1
Dear Cove,

I work for a major company making and distributing amon ther things medical xray scanners in Europe. Products are CE marked (as well as FDA approved...etc in most of the world)

Now, we have one customer that bought some xray equipment for research purposes. THey do not intent to use is as a medical device, will never scan patients or anything like this. They will scan some special types of stone.

THey have been asking us for a modified SW to accomodate their needs, however, some people in my organization claims this will violate the CE mark and is thus not allowed.

Can anyone guide me on this? Since the custoemr does not intend to use it as a medical device, is it possible legally to give the customer a modified SW version?

best regards
t.
 
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M

Mazoku

#2
Re: Customer wants cuztomized Software for Medical Device

Well, from what I read, The CE directive for medical devices says "This Directive shall apply to medical devices....'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings..."

However, since this will not be used as a medical device, and presumably not on humans, I'm not sure that statement or even directive applies, but I would think at that point it may fall under a completely different directive if any at all.

Don't quote me entirely on this, I have zero experience in the field. I work at an electronics company and the only ce directive we use is the low-voltage directive. But from my understanding I would say your co-workers are probably right.

More information can be found here:
http://ec.europa.eu/enterprise/poli...nufacturers/directives/index_en.htm?filter=16
 
Last edited by a moderator:
P

Philium

#3
It's a while since I worked with CE but from what I remember, you state which CE directives your product meets. See what those directives say about S/W updates would seem a good place to start. If they do not allow updates / modifcation to the S/W could you just remove your declaration that it meets that directive (and send the customer a new nameplate)?
 

rob73

looking for answers
#4
Talk to your notified body and explain what is required, they will advise what will be best. If i had to hazard a guess you will need to re-ce mark to the machinery directive as this the equipment will still need ce mark, but not a medical devices one.
 
#5
If you chose to create a variant that you decide is not a medical device it still needs a CE mark (for sale in the EU). But now the directives that may apply include:

Machinery Directive
Low Voltage Device Directive
EMC Directive
RoSH Directive (until July medical devices are excluded)

If you have a look at those directives the list of "Essential Requirements" would seem, in comparison to MDD, to be short and simple. And it would probably be quite straight forward to create a checklist against those requirements.

The difficulty may come from the list of Harmonised Standards for each of the directives that apply. For instance, under MDD EN60601-1 is used to prove electrical (and other) safety. Under LVDD you would be looking at 60950 or 61010.

You could state that the product testing is comparable or more stringent, but that would probably require detailed side-by-side comparisons to prove your point.

And I would not expect a Notified Body to be able to help much. Your MDD auditor would probably be limited to just MDD and they aren't allowed to provide guidance/consultancy.
 
T

temujin

#6
THanks a lot folks...

I think we will leave it as it is.
Since we are only a sales/service branch and the NB is located in a different country, that path will definitely be to long .:)

Thanks for your advices anyway.

regards
t.
 
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