Letter from The EurOpean Commission

Regarding the use of standards for marking of medical devices in 2013


I inquired at the EC due to the fact that the new standard EN 15223-1:2012 was not listed in OJC 022 list of harmonised standards for Medical Devices (of 24-01-2013). Upon sarching ths list i found that the old EN 980:2007 was not listed either. So there currently is NO standard for marking of medical devices.


(As we sell font files containing symbols for the marking of medical devices for both EN 980 and EN 15223-1 , it is relevant for us to recommend the right set of symbols to our customers.)


Reply from the European Commission on February 1st 2013

Dear Mr Gremmen,

EN980:2008 (Symbols for use in the labelling of medical devices) has been
deleted from Harmonized Standard and is intended to be superseded by new
standard EN ISO 15223-1:2012.

However, due to deficiencies of the new standard, our services had to
delete it from the OJ publication and, to this end, in the standards
publication database. According to the program of this database, the
superseded standard  EN 980:2008  was unfortunately deleted as well. This
is linked to the fact that CEN-CENELEC loads-up the standards in the
standards publication database, and the Commission's role is limited to
deleting deficient standards. The Commission cannot re-introduce standards
into the database.

Our services are of course not pleased with the deletion of the superseded
standard. Accordingly, the standards publication database now needs to be
re-programmed to avoid the automatic disappearance of superseded standards
in case of deletion of deficient new (superseding) standards. Pending this
re-programming, we will try to re-insert EN 980:2008 into the next

Best regards,

Anna Tamarit
European Commission


(to be continued)