Implementation of MDR and IVDR — Webinar Recordings
From 9 - 13 November 2020, the HPRA ran a series of online information sessions. The webinar series was designed to provide insights into some of the practical applications of the Medical Device Regulation and the In Vitro Diagnostic Regulation requirements in the areas of economic operator obligations, remote inspections, EUDAMED and registration, clinical data and IVDs.
Recordings of the webinars are available to view below.
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MDR and IVDR update: Overview and status of EU and national implementation
This webinar presentation covers two topics.
In part 1 (2:29-23:29) Dr Anna Eva Ampelas of the European Commission provides a status update on MDR and IVDR implementation and also provides an update on notified body designation.
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In part 2 (24:50-48:28) Dr Niall MacAleenan provides an overview of the national work in place to ensure the effective implementation of the MDR and IVDR at a national level.
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IVDR update: IVD classification rules and performance evaluation
This webinar presentation covers two topics.
In part 1 (1:40-23:01), Avril Aylward provides an overview of the practical considerations relating to IVDR classification rules and some key implications for consideration.
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In part 2 (23:44-40:51), Dr Philip Kelly provides an overview of the key requirements relating to IVDs and performance evaluation.
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Economic operator obligations, Eudamed and national registration requirements
This webinar presentation covers two topics.
In part 1 (2:33-26:00), Andrew Dullea provides a practical overview of economic operator obligations and responsibilities within the supply chain under the MDR. This presentation will focus on Articles 13 and 14 of the MDR.
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In part 2 (27:15-50:32) Andrea Hanson provides an update on Eudamed’s development and national registration requirements.
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Market surveillance, remote manufacturer inspections and distributor inspections
This webinar presentation covers three topics.
In part 1 (1:50-15:56) Dhanashree Gokhale provides an overview of the HPRA’s application of market surveillance activities and outlines the competent authority perspective on lifecycle market surveillance.
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In part 2 (16:12-24:40) Adrian Mahon covers the HPRA’s remote inspection activities and what to expect from a HPRA remote inspection.
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In part 3 (24:54-47:43) Barbara Henry provides a status update on HPRA distributor inspections as well as the key learnings from previous pilot inspections undertaken to date.
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Sufficient clinical data, equivalency for legacy devices and the CIE 2021 work programme
In this webinar presentation, Dr Tom Melvin provides an update on European Commission guidance documents, MDCG 2020-5 and MDCG 2020-6 concerning sufficient clinical evidence for legacy devices and equivalence, as well as an update on the Clinical Investigation & Evaluations (CIE) WG’s 2021 work programme.
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