Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

2. Technical Documentation

• Notified Body Interaction • New engagements/Relocating/consolidation

• Availability challenges has been widely reported and experienced • Will have a financial, compliance and time impact on placement on market • Implementing acts and guidance • Standards Update

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3. Clinical Evidence

• Performance Evaluation mandatory for all IVDs • Clinical Evidence potentially required for all IVDs • Performance Evaluation

– Analytical Performance Report – Clinical Performance Report – Scientific Validity Report

(these are all new and have to be created) • Joining the dots up of design history •

Providing a narrative linking all parts of performance evaluation, risk and intended purpose

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