Summary

As the European Union (EU) does not have a Food and Drugs Administration (FDA), the task of harmonizing and regulating medical devices is handled by the European Commission in close cooperation with member state health authorities.

The purpose of the EU harmonization effort is to merge the differing national requirements into one law which can be applied throughout the European Union.

Legislation adopted through this process covers implantable, non-implantable and in vitro diagnostics medical devices in three separate directives that provide manufacturers the basics to certify their compliance with EU-wide safety requirements.