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, ‘13 to Jul 1, ’15.

For access to the current list of Harmonized Standards, published Jan 24, ’13, they are available thru our previous post FDA & EU MDD / AIMDD / IVDD Updated Standards Lists.

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.