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SELECTBIO Conferences Point-of-Care, Biosensors and Rapid Diagnostics Europe 2023

Erik Vollebregt's Biography

Erik Vollebregt, Partner, Axon Lawyers

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.

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Where are Things with the IVDR?

Tuesday, 20 June 2023 at 14:00

Add to Calendar ▼2023-06-20 14:00:002023-06-20 15:00:00Europe/LondonWhere are Things with the IVDR?Point-of-Care, Biosensors and Rapid Diagnostics Europe 2023 in Rotterdam, The NetherlandsRotterdam, The

The EU IVDR has completely shaken up the EU regulatory environment for market access and regulation of IVDs in Europe. It has been and continues to be plagued by bottlenecks, capacity issues and lack of essential elements for implementation (such as the Eudamed database, designation of reference labs and essential guidance). It has been amended to change the transitional regime early 2022. Where are things with the IVDR at this moment? This presentation will give an overview of the state of affairs of the EU IVDR at the moment and what things are crucial for IVD companies to take into account for a successful transition to the IVDR.

Add to Calendar ▼2023-06-19 00:00:002023-06-20 00:00:00Europe/LondonPoint-of-Care, Biosensors and Rapid Diagnostics Europe 2023Point-of-Care, Biosensors and Rapid Diagnostics Europe 2023 in Rotterdam, The NetherlandsRotterdam, The