This looks like an interesting webinar invitation that was emailed to me.
Date: November 10, 2020
Time: 8:00 am PDT / 11:00 am EDT
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 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.
This regulation in 2022 has me hopeful.
"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."
The MDx landscape has been skewed to favoring lab developed tests. The bar is much higher for the approval of POC IVD assays. This also definitely the case in the US.