The COVID-19 pandemic created a paradigm shift in modern healthcare, where regulations, protocols, and mindsets had to be reworked in just a matter of months to keep up with the pace of the virus. In particular, the in vitro diagnostic (IVD) market experienced a dynamic never seen before: SARS-CoV-2 tests were developed at a record-breaking pace amid global supply shortages as labs struggled to keep up with unprecedented demand.
Although the pandemic is far from contained, the next challenge for the global IVD market lies around the corner. In Europe, the new Medical Device Regulation and IVD Regulation (IVDR) goes into effect on 26 May 2022, and will bring significant changes to the IVD testing space, with CE certification by a notified body becoming the rule rather than the exception and a new strict EU regime for in-house developed tests. Moreover, the Brexit transition period ends in December this year and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued post-Brexit guidance on IVD in the UK. This will not only impact IVD manufacturers, but also have far-reaching consequences for supply chain and distribution, notified bodies, as well as clinical laboratories who are operating in Europe.
In this webinar, Erik Vollebregt, an expert in IVD law from Axon Lawyers, will bring you up to speed on the IVDR and will discuss the impact of the current COVID-19 pandemic on future IVD testing.
Attendees of this webinar will learn:
- Basic outlines of the new EU IVDR regime
- New IVDR requirements around component specifications and maintenance
- Impact of the IVDR regime on supply chain and in-house developed tests
- EU emergency guidance in the field of IVD development
Our webinar speaker:
Erik Vollebregt, LLM, is one of the founding partners of the life sciences niche firm Axon Lawyers in Amsterdam. He has more than 20 years of legal and regulatory experience in the EU and Dutch national life sciences regulation. He specialised in regulatory and legal advice, contracts, mergers and acquisition work, and litigation in the life sciences sector, with a focus on medical devices, diagnostics and medicines. Additionally, he is an arbitrator and expert witness in foreign litigation. Vollegregt is an active contributor to development of EU and Dutch law in the life sciences field through national and international EU and US trade associations and EU and Dutch advisory committees. He has degrees in Dutch law from Groningen (Netherlands) University and in European law (post doc) from Stockholm (Sweden) University.