IVDMDD Harmonized Standards

Application of Harmonized Standards to your product provide the foundation on which the fulfillment of the Essential Requirements is established. These Harmonized Standards documents are copyrighted (ISO Norm, EN Norm). They may be obtained from a variety of vendors of your choice. For further information, we recommend consultation of the ISO – International Organization for Standardization .

To identify which Harmonized Standards potentially apply to your specific product, simply click the links below to obtain an overview.

IVD Horizontal Harmonized Standards

• IVD Design
• IVD Electrical Safety
• IVD Labelling
• IVD Manufacturing

IVD Horizontal Harmonized Standards

• IVD Quality Systems
• IVD Risk Management
• IVD Sterility
• IVDMDD Horizontal Harmonized Standards

NOTE: The ISO Norms and EN Norms displayed on subsequent pages are those Harmonized Standards, which have been published within the Official Journal of the European Communities as required by regulation (Status as of 1 April 2014). This does not exclude the application of supplemental standards or indeed alternative standards given the characteristics of specific products and with the alignment of the Conformity Assessment authority.