As you may know if your laboratory does business in Europe, the European Union (EU) has been planning to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). Those implementation plans had to be put on hold due to the COVID-19 pandemic. But on June 7, the European Commission’s (EC) Medical Device Coordination Group (MDCG) unveiled a new joint IVDR implementation and preparedness plan (Plan). Here is a compliance briefing on the Plan. Diagnostics Device Regulation in Europe In April 2017, the EC and the European Parliament adopted the EU legislative framework for regulation of medical devices, comprised of two parts: i. the new medical devices regulation (MDR); and ii. the IVDR. The plan was for the MDR to apply starting in May 2020, to be replaced by the IVDR in May 2022. But things did not go as planned. In response to the pandemic, the MDR was postponed to May 26, 2021; but the May 2022 implementation date/compliance deadline for the IVDR was not postponed. To make the transition and prepare for compliance with the IVDR, labs, authorized representatives and other stakeholders must carry out major operational tasks such as revising documentation about their products, […]