MDD Harmonized Standards Updated

The European Commission updated the list of standards harmonized to the Medical Device Directive (MDD) on May 13, 2016. The list is available at

The new list does not include the EU versions of ISO 13485:2016, IEC 62366-1:2015, or Amendment 1 to IEC 62304:2006.

The new standards are: EN 556-2:2015, EN 1865-1:2010+A1:2015, EN 1865-2:2010+A1:2015,

EN ISO 3826-4:2015, EN ISO 11137-1:2015, EN ISO 11137-2:2015, EN ISO 13408-1:2015, EN ISO 13408-7:2015, and EN 60601-1-2:2015.