Is it compulsory to print the CE mark on our software & user manual CD-ROM

NewRegMan

Starting to get Involved
#1
Hi everybody,

I wonder whether it is compulsory to print the CE mark on our software & user manual CD-ROM even if the containing software is not a medical device according to the intended use or not.

The CD-ROM contains a software application that allows
generating reports from data of our device trainings and assessments recorded and the corresponding user manual.

Any idea are very welcome.

Thanks in advance!:thanks:

Best regards,
Guido
 
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GStough

Staff member
Super Moderator
#3
Hi everybody,

I wonder whether it is compulsory to print the CE mark on our software & user manual CD-ROM even if the containing software is not a medical device according to the intended use or not.

The CD-ROM contains a software application that allows
generating reports from data of our device trainings and assessments recorded and the corresponding user manual.

Any idea are very welcome.

Thanks in advance!:thanks:

Best regards,
Guido
Hi Guido,

I'm no expert on CE Marking, but since no one else has offered to help, I thought I would try. :)

According to Article 1 Definitions, Scope of the MDD, your software and CD-ROM might at most be considered an accessory, which "...means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device."

And as stated in paragraph 1 of the same Article mentioned above, "...accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices."

My suggestion to you would be to review these definitions,keeping in mind your device's software/CD-ROM which accompanies it, and seek the guidance of your Competant Authority and/or European Representative who will be more familiar with your device and its software than anyone here in the Cove, try as we might. :)

Hopefully, someone with more expertise in CE Marking will come along and offer more advice. ;)

Hope this helps, though...
 
C

cwokeeffe

#4
Guido,

We define our CD-ROMs as an assessories, but without the CE mark ran into significant problems importing them into several countries. I would consider your market, how and when you are shipping them.

Colleen
 
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