Selling of Research products in Europe

C

CBAL08

#1
Are there any regulations in EU for manufacturers who would like to sell stand-alone software for Research purpose ONLY for example imaging software but not for clinical use? Please help.
 
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sreenu927

Quite Involved in Discussions
#2
If a product is labeled as "For Research Use Only", you can sell it without any registration as it is not a medical device. However, to place CE marking on the product labelling, you have to check for applicable EU Directives and/or standards to draw Manufacturer's Declaration of Conformity.


In any case, if you have doubt ion product classification, you can refer to Borderline Manual from below link:

http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf

Regards,
Sreenu
 
C

CBAL08

#3
If a product is labeled as "For Research Use Only", you can sell it without any registration as it is not a medical device. However, to place CE marking on the product labelling, you have to check for applicable EU Directives and/or standards to draw Manufacturer's Declaration of Conformity.


In any case, if you have doubt ion product classification, you can refer to Borderline Manual from below link:

http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf

Regards,
Sreenu
Thank you for the response. However, can the reserach Product be sold without the CE marking?
 

Pads38

Trusted Information Resource
#4
If you decide that your device is research only, and thus not a medical device you are not then compelled to comply with the medical device directive.

However, you may, instead, have to comply with one or more other European directives. As an example consider an physiological signal amplifier - you decide it is research only so not MDD. But instead it might fall into the Low Voltage Device Directive, the EMC Directive, the RoSH directive and the WEEE directive. The first three of those are all "CE" marking directives.

For a device that is software only I am not aware of any directives other than MDD that might apply. However, I would suggest that it would be "good practice" to consider the Essential Requirements of the MDD and apply those that would otherwise be applicable. I am here thinking about such things as making sure that the software is identifiable, with the manufacturer, type, version, configuration etc all being clearly shown.
 
C

CBAL08

#5
Thank you for your response.

Still wondering what are the other Directives if not Medical Device that will be applicable for such software. Are there any regulations in europe for selling such Software for research purpose ONLY?
 
B

blargon

#7
Here's another elsmar thread that may be useful:
[Edit: I can't post links until after a few more posts. The thread title is 'RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements ']

I don't think there are specific directives covering software for medical imaging research purposes only. But no harm to aim to comply with CE marking directives if considering selling a version of the software package for diagnostic / therapeutic use in the future?Or as 'good practice' as Pads38 said
 
C

CBAL08

#8
Our device is analytical software, to be used in a basic research environment, indeed not in any diagnostic procedure.

It will be used to provide data to support e.g. medicine studies (clinical trials) or the writing of scientific publications (research institutions).

Does this RUO label also apply here, although it is no IVD?

Do you have any references to FDA/US (or European) regulations that can provide us with a legal basis for doing this?
 
B

blargon

#9
Have you reviewed MEDDEV 2.1/6:[FONT=&quot] Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices[/FONT]

In particular, Figure 1: A decision diagram to assist qualification of software as medical device.
 

c.mitch

Quite Involved in Discussions
#10
Hi
I'll take an example.
Do you know Osirix?
It's a famous open-source standalone medical imaging software. It is made for research and educational purposes only. As such it has no CE mark, but it often used by universities and research labs in Europe.
But there is german company which repackages it for clinical use, with a new name. As such the repackaged software is CE marked.
Thus, by comparison with this example, your software wouldn't require the medical CE mark.
All the rationale is based on the intended use: research->no CE, clinical->mandatory CE.

BTW your device is standalone software and is not subject to other "types" of CE marks mentioned in post #4.
 
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