Notified Body Medical Devices

The role of a Notified Body is to conduct a conformity assessment under the relevant EU Directives and Regulations. The Notified Body conducts the conformity assessment against the relevant sections of the applicable Directive (MDD, AIMDD or IVDD) or Regulation IVDR, MDR).

The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the device, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device.