First lists of harmonized standards published for Regulations for medical devices
Eamonn Hoxey
![Eamonn Hoxey]()
Eamonn Hoxey
Retired from technical writing, training and consulting - quality & regulatory compliance, sterility assurance, standards development
European Commission decision lists first standards with a presumption of conformity
The European Commission has published lists of the first standards to be harmonized under the Medical Device Regulation - 2017/745,?(MDR) - and In Vitro Diagnostic Medical Devices Regulation – 2017/746 (IVDR).?The publication of the Commission Decision with the list of standards follows the acceptance of the Standardization Request by the European Standards Organizations, CEN and CENELEC.