What is the role of a Notified Body and UK Approved Body?

The role of a Notified Body and a UK Approved Body is to conduct a Conformity Assessment under the relevant EU Regulations (MDR and IVDR) and UK legislation, respectively.

The Conformity Assessment usually involves an audit of the manufacturer’s quality system (QMS) and, depending upon the device classification, a review of the relevant technical documentation provided by the manufacturer in support of the Safety and Performance Requirements (EU) or Essential Requirements (UK) for the device.