Module 17 2024

05/12/2024

Implementation of UA’s by Notified Bodies

• Testing of sample devices is required to be carried out during unannounced audits • Comparison of testing results on a sample or 100% basis during in-process or final inspection, with equal testing performed during design verification, to ensure that specifications are aligned with the Technical Documentation for the finished device (including, if practical witnessing the realization of such testing at the site) • For Class III devices, testing of sample devices is required during UAs. If possible testing is conducted on-site during UA. Otherwise, samples will be obtained, and testing either be conducted at a different time or a 3 rd party test house will be used to conduct testing

The Organisation for Professionals in Regulatory Affairs

141

141

Insight into the practical application of Unannounced Audits

• The major objective of UAs is for the NB to collect evidence of the device's conformity in practice compared to what is described in the technical documentation; clear documentation! • The NB auditor's focus is to verify the conformity of (key) production processes (at least two) of the device at the audit against the information in the documented procedures (QMS) and technical documentation; clear documentation! • The NB auditor's focus is to verify the device's conformity in the warehouse/production chain against what is documented in the technical documentation; clear documentation! • The focus of the NB auditor is to verify the conformity of the (raw) materials used/processed/purchased in the medical device; against what is documented in the technical documentation; clear documentation!

The Organisation for Professionals in Regulatory Affairs

142

142

71