Final updates to the list of standards harmonised for the European medical devices directives
Eamonn Hoxey
Retired from technical writing, training and consulting - quality & regulatory compliance, sterility assurance, standards development
Commission Implementing Decisions for harmonised standards update list of standards in Official Journal
The medical devices directives (Medical Devices Directives (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC) have specific roles for harmonised standards in demonstrating conformity. Harmonised standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonised standards are presumed to be in conformity with the requirements of the Directive covered by those standards.
Three Commission Implementing Decisions for harmonised standards were adopted in April 2021 and published in the Official Journal. There is a separate decision for each of the three directives. These implementing decisions present the final updates to the list of harmonised standards that give a presumption of conformity for the directives for medical devices