Big changes in the world of EU harmonized standards

We note that there is considerable change in the world of harmonized standards. EN ISO 15223-1 will replace EN 980 as the recognized standard for symbols to be used in medical device labeling. Moreover, two of the most important standards for manufacturers in the European Community, ISO 13485 and ISO 14971, will see updated versions published.

When EN 980:2008 is officially withdrawn on 31 January, 2013, the European Norm standard will be superseded by EN ISO 15223-1:2012. While many of the symbols in EN 980 were largely in ISO 15223-1:2007/Amd 1:2008, both standards are now one international standard and the EN 980 EC REP symbol designating Authorized Representative has been added to EN ISO 15223-1. Additional symbols (not previously included in EN 980) are introduced via EN ISO 15223-1. These include humidity and atmospheric pressure limitations, sampling site, fluid path, non-pyrogenic, drops per mL, liquid filter, patient number, one-way valve, and protect from heat and radioactive sources.

The symbols listed above will need to be explained by the manufacturer in accompanying Instructions for Use or packaging. Moreover, EN ISO 15223-1 adds the “wine goblet” or “fragile, handle with care” symbol (which was not included in EN 980), but this symbol will not require additional explanation. 

Other significant changes include revisions of ISO 13485 and ISO 14971. While ISO 13485:2012 will not see any changes in the Normative Text and the requirements will remain unchanged, revisions have been made to the informative Annexes. These annexes now further clarify how the standard can be used to support the Essential Requirements of the medical devices directives. Emergo Group understands that ISO 14971, which is expected to be superseded this summer by an updated version (ISO 14971:2012), has only undergone slight revisions. Although the application of harmonized standards is not mandatory in the EU it helps demonstrate compliance with required elements (Essential Requirements, Annex I).

There may still be some time until these standards are officially harmonized by means of publication in the Official Journal of the European Union. Also, it has been mentioned that the draft medical device legislation will be publically available in September 2012. 

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