IVDR in light of the COVID pandemic:
The near future of in vitro diagnostic testing
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 May 26, 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 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.
Erik is a founding partner of Axon Lawyers. He specialises 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.