Aug 26, 2008
A very important update to EN 980 has just been released.
The new changes in this document are exciting and will certainly have a positive impact on medical device labeling. EN 980:2008 greatly increases the number of symbols that are recognized in Europe that can be used without further explanation.
The biggest change is that Clause 5 (Symbols in Use) has been greatly expanded to include a total of 29 symbols, up from 12 previously. These 29 symbols can now be used "without explanation in the information supplied by the manufacturer."
These are the 12 symbols from EN 980:2003, Clause 4 (now Clause 5 in EN 980:2008) that were considered "Already in Use" and needed no further explanation:
These 10 symbols were included in EN 980:2003, Clause 5, but were considered "New Symbols" and therefore needed to be "explained in the information supplied by the manufacturer." In EN 980:2008 (Clause 5), these are now listed as "Symbols Already in Use" and no longer need to be explained.
The following seven symbols were also added to EN 980:2008 (Clause 5) and were taken from ISO 15223-1:2007. They can be used without further explanation and include:
Finally, three entirely new symbols have been introduced. They must be explained in the information provided by the manufacturer:
The biggest impact of these changes to EN 980 is that the 10 symbols previously listed in EN 980:2003 Clause 5 (plus the additional 7 symbols from ISO 15223:2007) do not need to be explained. That means you no longer need to provide explanatory notes in your Instructions for Use, thereby simplifying translations and facilitating your compliance with the Essential Requirement that encourages the use of symbols.
As 2011 winds down, we write you with some final news for the year from the European Union.
As we mentioned last year, the Central Management Committee (CMC) on Medical Devices made a decision in 2011 that affects labeling for manufacturers and
The recast of the RoHS Directive (Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment) has been adopted and was published in the Official Journal of the European Union (OJEC) in July of this year. Compliance to the directive is demonstrated through CE Marking.