Label on Miniature Active Class I Medical Device

J

Jabaheikant

Registered
#1
#1
Dear community,

Our company is manufacturing a Class I active device which measures just 25mm (length) x 15mm (width) x 10mm (height). Some surfaces are furthermore impractical to print any information on. The re-usable device will be used by non-professional users and packaged individually.

The MDD (article 13.1, third paragraph) states that the labelling information should be on the device itself 'as far as practiable and appropriate'.
Does any of you know what this criterium means in practice?

Due to its Class I certification, the device will follow a self-certification route so there won't be a Notified Body inspecting the labelling (unless as part of our ISO 13485 audits), but I'd nevertheless like to know what they would see as the absolute minimum information to be supplied on the device itself.

Thanks in advance!
 
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