EN ISO 15197:2015 - Glucose meters that were CE marked to EN ISO 2013




ISO 15197:2013 was first published on May 13 of 2013 with a three year transition period. On May 13 of this year, the Official Journal of the European Union updated the standard from EN ISO 15197:2003 to EN ISO 15197:2015 (ISO 15197:2013) with a note saying "For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017."

What is confusing is that up until last month, EN ISO 2003 was listed as the harmonized standard and now it is saying that EN ISO 2015 has superseded EN ISO 15197:2013 (which has never been publicly listed as harmonized) and that the date of cessation of presumption of conformity to the superseded standard (is this 2003 or 2013...this is the critical point) will be 2017.

Does this mean that the glucose meters that were CE marked in accordance with the EN ISO 2003 need to be taken off the market immediately or by 2017? This is really confusing because they are listing EN ISO 2013 as the superseded standard.

Please help!! My Notified Body is confused as well and they are trying to contact their headquarters and competent authorities, but they are taking way too long.



Super Moderator

without being familiar with blood-glucose monitoring systems at all, some general remarks on harmonised standards and related updates:

1) Compliance to harmonised standards is only one possible way to demonstrate (actually "presume") conformity with the essential requirements of the MDD. Although definitely tedious and a very tough path to go, you could choose to establish conformity differently.

2) Most of the times, it is more straightforward to stick to the harmonised standards: in this case, perform a documented gap analysis, comparing the predecessor version of the standards and ist successor version. Evaluate what the identified gaps mean for your product. In case of critical gaps you will have to closely work on a plan together with your NB how to move forward. And yes, worst case your device, e.g. if it is technically outdated and thus, not state of the art anymore, could lose its CE mark when the transition period for the new standard ends in 2017.


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