Part 3 in our 7-part series on meeting the new requirements under the EU MDR
If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.
A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.