Harmonised standards under the current Directives (AIMDD, MDD and IVDD) to respond to the unprecedented needs caused by Coronavirus pandemic
Posted on 02.04.2020
The EU Commission published three Commission’s Decisions to allow manufacturers to place on the market critical devices, such as medical face masks, surgical clothing, washer-disinfectors, sterilisation, ventilators, etc. Each Decision corresponds to one of the current Directives and includes a list of harmonised standards which grant conformity of devices with the requirements of the respective legislation. The decisions can be found here.