Class IIa Medical Device, CE Mark & 510k - Labeling Content

#1
We have a class IIa medical device with CE registration and 510k filing underway. For the 510k filing the IFU and labelling had to changed with among those changes a Rx only symbol. This triggered a discussion as the inteded use of the device contains: "shall be used in a clinical environment according to local legislation" and "is to be used by clinical staff according to local legislation".

However, nothing on our IFU and product labelling indicates this. On the US IFU and product labelling this is indicated by the Rx only symbol.
What do you think: is this sufficient for US?
How is this information normally communicated to the end user in Europe?
 
#2
From 21 CFR (801.201 (b)(1)):
"The symbol statement "Rx only" or "[rx] only" or the statement "Caution: Federal law restricts this device to sale by or on the order of a ___", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device"

The intended requirement is to ensure that only licensed healthcare professionals or their designates (i.e. under the order of those professionals such as unlicensed paramedics) can use it. We place "Rx only" on both the label and IFU and it was never an issue.

Does this previous thread from 2013 help?
 
#3
Sorry for my late reply (was out of office for a week). I have read the previous thread from 2013 and I agree that adding the 'Rx only' symbol on the label and IFU should be sufficient for the US market.

Also in the EU the device "is to be used by clinical staff according to local legislation". However, both the European label and IFU does not contain this information. I feel we should communicate this to the end user, however I am not sure how to go about this. Does anything like a 'Rx only' symbol/statement exist or Europe?
 

LarsZ

Registered
#5
What struck me in the PoM classification for medicines is the first sentence: "The legal classification of a pack of medicine determines the level of control over its supply." To me this would indicate that no symbol or statement is required, as long as the supply is controlled (how this is done for medicine is another discussion completely).

Does anyone know if such guidelines also exist for medical devices? Would control of supply only to professional users be sufficient as guidance to stay within our intended use? Or are these aspect of the intended use always communicated trough the label/IFU?
 

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