Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Annex IX – QMS and Tech Doc

 Chapter I: Quality Management System ● 1. QMS to be implemented according to art. 10.8 ● 2. QMS assessment by NB. – Extensive list of QMS elements. – Audit. – Inform NB of substantial changes in the QMS ● 3. Surveillance ● Surveillance audit at least every 12 months – Unannounced audit (at least once in 5 years) – Class C and B: include assessment of technical documentation based on sampling plan

The Organisation for Professionals in Regulatory Affairs

21

Annex IX – QMS and Tech Doc

Chapter II: Assessment of Technical Documentation ● Classes B , C & D ● Section 4. Assessment of Technical Documentation – Complete review in accordance with Annexes II and III – Class B and C NB will issue a report on the assessment for device sampled For Class D ● Testing by reference lab (opinion within 60 days) ● NB issues Technical Documentation Assessment Report including Performance Evaluation Assessment Report ● Approval of changes (possibly with reference lab involvement) ● Batch release

of 21

The Organisation for Professionals in Regulatory Affairs

22