The EU is not a federal State, but primarily an economic union of independent countries, called Member States.

The health and wellbeing of EU citizens remains the responsibility of the government of the individual Member State. Therefore each Member State has a government Ministry with responsibilities for the health and wellbeing of its citizens.

This ministry, (or an independent agency it establishes) is ultimately responsible for the ‘approval’, use, removal and disposal of medical devices used within a Member State. Throughout the EEA the ‘approval’ of medical devices is delegated to Notified Bodies.

A list of the Competent Authorities is available on the EU Commission Website. See Useful links.