If your laboratory company does business in Europe, it needs to be tuned in to the dramatic regulatory changes that are slated to go into effect in 2022. The key date is May 26 when the European Union’s (EU) ambitious new In Vitro Diagnostic Regulation (IVDR) is scheduled to go into effect. However, like just about everything else in public life, the COVID-19 pandemic has wreaked havoc on the implementation plan. Despite the snags, snafus delays and vehement protests from the laboratory industry, the European Commission’s (EC) Medical Device Coordination Group (MDCG) has stubbornly clung to the May 26, 2022 deadline. That is, until now. On Oct. 12, the Commission finally yielded to the inevitable when it announced that it would rollout the IVDR progressively, rather than all at once on May 26. Here is a quick briefing of the IVDR and the new rollout plan. EC Regulation of In Vitro Diagnostics The EC and the European Parliament adopted the ((EU) 2017/746) legislative framework for regulation of in vitro medical devices, such as HIV, pregnancy and SARS-CoV-2 tests back in April 2017. That new framework is made up of two parts: The new medical devices regulation (MDR); and The IVDR. […]