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This webinar presentation covers two topics.
In part 1, (3:30) Dr Niall MacAleenan provides an overview of the transition from the IVDD to the IVDR and some of the remaining system challenges. Dr MacAleenan also addresses medical device coordination and governance as well as HPRA priorities for the new regulatory system.
In part 2, (19:23) Sinead Duggan provides an overview of European and national implementation of the IVDR. Key transitional timelines and useful stakeholder resources are also covered.