EN ISO 13485:2016 harmonized

The EU-Commission published an updated list of harmonized standards on their website.

The new publication  includes among other newly harmonized standards  the EN ISO 13485:2016 as harmonized for the 3 directives:

  • 90/385/EEG AIMD
  • 93/42/EEC MDD
  • 98/72/EEC IVD


Please be reminded that this does not imply the presumption of conformity under the (EU)2017/745 MDR.

EN ISO 15223 superseding the EN 980

In the new table the EN ISO 15223:2016 is listed the first time as harmonized standard. It replaces by 2017-12-31 the former EN 980:2008.