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FDA Requirements for the Use of Symbols on Medical Device Labels

M

mark walker

#31
#31
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Dear Bonebuilder . Sorry You should really get out more as 980 was with drawn and then Reinstated as i said in my previous mail.

Please back up your comments because im affraid im correct this time:)
 
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M

mark walker

#32
#32
Re: Use of Symbols on Medical Device Labels - FDA Requirements

EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN[/B]

ISO 15223-1) Ooopppss!

Posted By leoeisner On @ In Uncategorized |


The EN 980
Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, 13 release and EN ISO 15223-1 Medical devices Symbols to be used with medical device labels, labeling and information to be supplied
Part 1: General requirements was anticipated to be Harmonized but it wasn't Harmonized under the MDD, AIMDD, or IVDD. The EU Commission has advised that the disappearance of EN 980 was a mistake and it is still Harmonized and will be corrected at the next release of the updated Harmonized Standards Listing, hopefully in the next few months. The EU Commission didn't Harmonize
the EN ISO 15223-1 because they saw issues in relation to the Directives (MDD, AIMDD, & IVDD) and Annex Z?s (e.g. Annex ZA, ZB, ZC) of the standard EN ISO 15223-1:2012. Because the standard EN ISO 15223-1 wasn?t Harmonized under this last round by the EU
Commission CEN extended the date of withdrawal of EN ISO 15223-1:2012 from Jan 31, 2013 to Jul 1, 2015.
For access to the current list of Harmonized Standards, published Jan 24, ?13, they are available thru our previous post DA & EU MDD / AIMDD / IVDD Updated Standards Lists

[1]

Christine Ruther, an Eisner Safety Consultants Associate reminded us The directives already allows the use of symbols from non-harmonized standards with the stipulation that the symbols and colours must be described in the documentation supplied with the device (e.g., MDD Annex I item 13.2). As most manufacturers define all symbols, regardless of origin, this gap in a harmonized standard for symbols should not be an issue.

In any event, manufacturers are expected to take a common sense approach to managing the situation. This will likely entail writing a short quality plan that acknowledges the situation and defines what actions will be taken. Actions might include waiting for the next update of harmonized standards to confirm which standards are harmonized, reviewing existing use of symbols to confirm compliance with EN ISO 15223-1 in anticipation of the change, or other actions.

NOTE: It is not clear, at this point, if the EU Commission will Harmonize EN ISO 15223-1:2012 for the next publication of the List of Harmonized Standards for the MDD, AIMDD, & IVDD. For Christine?s part of this post we should also thank NSAI for forwarding information on this
momentary vacuum.

Article printed from Eisner Safety Consultants:

http://www.eisnersafety.com

URL to article:

http://www.eisnersafety.com/eu-mdd-aimdd-ivdd-harmonizedstandards-
en980-en-iso-15223-1-ooopppss/

URLs in this post:
[1]

So ithink im owed a apology Mr Bonebuilder?
 
B

Bonebuilder

Starting to get Involved
#33
#33
Re: Use of Symbols on Medical Device Labels - FDA Requirements

bsi certainly think that it has been withdrawn, take a look, you'll find it at..

BS EN 980 is the standard for symbols for use in the labelling of medical devices

and I just got off the phone with their knowledge centre who say they are certain that 980 was withdrawn and replaced by 15223 in January. They are thou going to contact the council and come back to me to confirm.

Your right I should get out more but there it is! I'm clearly not as up to date in my reading of these postings as your good self...!

Any potential apology is therefore very much on hold until we have some impartial confirmation.

Regards
 
Last edited by a moderator:
M

mark walker

#34
#34
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Sorry Bsi huh. Knowledge centre behind the times , so i still await a apology, or do i need to to talk You through the intent of Z annexes as well?

Happy to educate:bigwave:
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#35
#35
Re: Use of Symbols on Medical Device Labels - FDA Requirements

News flash from FDA:

The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a "standardized symbol'') and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement "Rx only'' on the labeling of prescription devices.
Click to expand...
Read more: http://www.gpo.gov/fdsys/pkg/FR-2013-04-19/html/2013-09175.htm?source=govdelivery
 
R

redknight07

#36
#36
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Has there been any developments with regards to the proposed rule as to when it would be implemented?
Thanks,
AK
 
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