Manufacturers' products meeting 'harmonised standards'[1] have a presumption of conformity to the Directive.

Products conforming with the MD Directive must have a CE mark applied.

The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made.

Compliance with the revised directive became mandatory on 21 March 2010.

[citation needed] The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745),[2] effective on 26 May 2021.