In Vitro Diagnostic Medical Devices Regulation – webinar recordings
On 9 May 2022, the HPRA held a webinar on the In Vitro Diagnostic Medical Devices Regulation (IVDR), which covered key topics and provided practical information regarding the application of the IVDR.
The webinar provided insights into key areas such as the national and European implementation of the regulations, post-market surveillance, vigilance and registration requirements, as well as HPRA inspections and performance studies.
View the video recordings and presentation slides from the webinars below.
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European and national implementation of the IVDR
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 regulatory system coordination and governance as well as HPRA priorities for the new regulatory system.
In part 2 (19:23), Sinead Duggan provides an overview of the European and national implementation of the IVDR. Key transitional timelines and useful stakeholder resources are also covered.
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Post-market surveillance, vigilance and market surveillance
In this webinar presentation, Elaine Kilbane provides a practical overview of post-market surveillance, vigilance and market surveillance requirements under the IVDR. This presentation covers a range of important topics including the key changes that economic operators should be aware of, incident and FSCA reporting timelines as well as our own market surveillance system.
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HPRA IVD inspection activities
In this webinar presentation, Dr Jennifer Roche provides an overview of the HPRA IVD inspection activities. This overview covers our role regarding inspections, the different types of inspections, the inspection process as well as key changes for different inspection candidate types and their obligations under IVDR.
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Performance studies
In this webinar presentation, Dr Philip Kelly provides an overview of performance study requirements under the IVDR. This presentation provides practical information about the different types of performance studies under the IVDR and outlines their corresponding requirements. It also addresses how to submit an application or notification for a performance study or study modification.
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Registration requirements and certificates of free sale
In this webinar presentation, Andrea Hanson provides an overview of economic operator and IVD registration requirements and certificates of free sale (CoFS). This presentation clarifies how economic operators should register their device and organisation details. It also addresses the key transitional deadlines to look out for and how economic operators can apply for a CoFS for their IVDs.
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