IFU (Instructions for Use) Label Symbols Requirements

K

karha096

#1
Hi all,

Let's say I use the symbol for irradiation sterilization on the label of a sterile implant. Do I have to print the symbol in the instrucitons for use?

My current thinking is that 13.6(a) stipulates that all information (with a few exceptions) that is printed on the label also needs to be included in the IFU. This would include the symbols, right?

Do you have any input on this?

/K
 
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Michael Malis

Quite Involved in Discussions
#2
Re: Label symbols also in IFU?

Hi all,

Let's say I use the symbol for irradiation sterilization on the label of a sterile implant. Do I have to print the symbol in the instrucitons for use?

My current thinking is that 13.6(a) stipulates that all information (with a few exceptions) that is printed on the label also needs to be included in the IFU. This would include the symbols, right?

Do you have any input on this?

/K
The short answer is yes!

You need to explain your symbols in the IFU. Also some areas of the world (such as Canada) do not recognize or accept the use of symbols. In order to make use of symbols, a legend defining these symbols must accompany the product.

Hope this helps,
Mike
 
K

karha096

#3
Thanks, but my question is not whether you need to explain the use of symbols you invent yourself, but rather if the symbols standardized by 980 aslo need to be printed in the IFU.
 

Michael Malis

Quite Involved in Discussions
#4
Thanks, but my question is not whether you need to explain the use of symbols you invent yourself, but rather if the symbols standardized by 980 aslo need to be printed in the IFU.
My message above was referring to allsymbols. Regardless of ISO 980, ISO 15523 or any others, - all symbols must be explained in the IFU.
This action is allowing regions and countries that are not familiar with EU regulations to understand it.
 
M

MIREGMGR

#5
The labeling for a device that is marketed/used only within the EC only needs to explain those symbols that are not standardized in EN980 or ISO15223.

The labeling for a non-OTC device that is marketed/used in the US, if it includes symbols other than the limited set that are listed in the FDA guidance "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" (2004 edition), must include English text that explains the symbols. Some FDA examiners expect the use of English text with all symbols. The FDA does not recognize EN980 and ISO15223.

The labeling for a non-OTC device that is marketed/used in Canada must state and identify certain information in either English or French text. I'm under the impression that the use of symbols for other information, or symbols in addition to the required text in the case of specifically required information, is allowed.

Requirements in other countries are dependent on their medical device regulatory systems. Many countries allow importation of devices that are labeled to conform with FDA or EC requirements, for instance, and those regulatory systems do not require the inclusion of a separate IFU in certain circumstances.
 
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Michael Malis

Quite Involved in Discussions
#6
...The labeling for a non-OTC device that is marketed/used in Canada must state and identify certain information in either English or French text. I'm under the impression that the use of symbols for other information, or symbols in addition to the required text in the case of specifically required information, is allowed....
:nope:CANADA does not recognize or accept the use of symbols without package insert or leaflet defining those symbols! Also only Quebec province, require French language.
 
Last edited:
M

MIREGMGR

#7
:nope:CANADA does not recognize or accept the use of symbols without package insert or leaflet defining those symbols! Also only Quebec province, require French language.
Could you provide a link or reference to that restriction in HC's "Guidance for the Labelling of Medical Devices (...)" or the "Medical Device Regulations"?

As to languages...Section 23 of the "Medical Device Regulations" and Section 1.3 of "Guidance for the Labelling of Medical Devices (...)" both state that information required to be provided on a device label (except for manufacturer name/address and the product's identifying and batch-code numbers) shall be in English and French if the device is to be sold to the general public, and in either English or French or both if the device is for professional use only, with the device's IFU available to be provided in the other official language upon request. There is no mention in either document of Quebec specificity.
 
C

Cinti

#8
Hi,

I need one information. EN 980:2008 contains 29 symbols. can anybody list out the symbols that should be print out in labels, carton box and IFU.
 
M

MIREGMGR

#9
EN 980:2008 contains 29 symbols. can anybody list out the symbols that should be print out in labels, carton box and IFU.
Each of the standardized symbols communicates the proper action or understanding in regard to some circumstance. You determine which of those circumstances apply to your product, then use the corresponding symbols.

In most instances, it's appropriate for the same information to be communicated on both the box/case/carton label and the individual-product label. If the individual-product label carries the full range of regulatory and safety/effectiveness information to be communicated, the IFU may be focused only on its specific task of instructions for use. There is however no harm in repeating on the IFU the information from the labels, as long as it is correct and consistent.
 

sreenu927

Quite Involved in Discussions
#10
Hi Cinti,

All it depends on your type of medical device. What is your device?

As a minimum, every medical device requires, SN or LOT, REF, Manufacturing date, Use by date, Consult Instructions for Use, Manufacturer, if requires sterilization, then type of sterilization symobl, if for single use, then single use only symbol, if IVD, IVD symbol, etc...

Regards
Sreenu
 
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