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Label Placement Requirement in MDD/MDR

#1
Hi, we're developing a Class I medical device, it will be used by only physicians. Our device is of size to be fit in a palm. It's a mobile device to be carried on the physician. Do we have to put the device label on it? For design considerations, we do not want to put all the symbols, the name of the manufacturer and the long address on this device. Is it enough to just put the CE mark and some important symbols on the device and leave the rest to the box label or user manual? Or can we put this info like the manufacturer, address, manufacturing date, device ID, etc. somewhere inside the device?

I could find specific info or clue for the placement of the label in MDD or guidance documents. I would appreciate your help.
 
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dgrainger

Trusted Information Resource
#2
Annex I - Chapter III - 23.1b
(b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.

and then look at 23.2. "Information on the label:"
 

Haresh

Involved In Discussions
#3
Dear dgrainger,
Thanks for above valuable information.
I have one question is that though we have valid CE certificate as per MDD (Validity 2024). Still we have to comply the labelling requirements as per EU MDR 2017 after 26th May 2021.
Awaiting your reply,
 
#4
Dear dgrainger,
Thanks for above valuable information.
I have one question is that though we have valid CE certificate as per MDD (Validity 2024). Still we have to comply the labelling requirements as per EU MDR 2017 after 26th May 2021.
Awaiting your reply,
Yes, I have the same question. We are compliant under MDD until 2023. Which MDR requirements are necessary with an MDD Cert. to ship to the EU? As far as I understood, nothing had to change until our MDD cert expired. We could continue to market to the EU as before. Must we use an importer/economic operator already? Does the IFU need to be MDR compliant? Must we have the Basic UDI-DI?
 
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