17. November 2017

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.