Module 19 2021

24/05/2021

Annex IX – QMS and Techical Documentation

Chapter I: Quality Management System ● 1. QMS to be implemented according to art. 10.8 ● 2. Initial QMS assessment by NB. – Extensive list of QMS elements. – Audit will include processes for implementation of IVDR requirements (e.g. Art 10.8 (a) strategy for regulatory compliance) – 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 B and C: include assessment of technical documentation based on sampling plan

The Organisation for Professionals in Regulatory Affairs

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Annex IX – QMS and Tech Doc

Chapter II: Assessment of Technical Documentation ● Section 4. Assessment of Technical Documentation by sampling for Classes B and C – Complete review in accordance with Annexes II and III – Class B and C NB will issue a report on the assessment for device sampled ● Technical documentation assessment for Class D – Performance evaluation testing by EU Reference Lab for Class D devices(opinion within 60 days) – NB issues Technical Documentation Assessment Certificate following positive Performance Evaluation Assessment Report from EU Lab – Approval of changes (possibly with reference lab involvement) – Batch release

The Organisation for Professionals in Regulatory Affairs

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