In the context of medical devices, a Notified Body is an independent organisation designated by a European Union (EU) member state to assess and verify the conformity of certain products with the applicable regulatory requirements.  Notified Bodies play a crucial role in the conformity assessment process – a key step for placing medical devices on the EU market – and undertake multiple other important functions, including: Conformity Assessment QMS Audits Product Certification Ongoing Surveillance Technical Expertise