Any systematic investigation or study in or on one or more human subjects,
undertaken to assess the safety and/or performance of a medical device.

Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. 

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives.

The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices.

Nando (New Approach Notified and Designated Organisations) Information System