ARTICLE SUMMARY:
The official date of application for the EU IVDR has arrived, setting into motion a multi-year rollout of compliance deadlines. Here’s a look at where things stand.
The In Vitro Diagnostics Regulation is the official law of the land in the European Union as of Thursday, May 26, when the five-year transition clock for the 2017-enacted IVDR ticks to zero. What that means can vary a bit depending on the particulars of each manufacturer and test. In response to COVID-19 challenges, the EU agreed to stretch out IVDR compliance deadlines for tests placed on the market before May 26, with risk-based phase-in dates ranging from 2025 to 2027.
But, starting now, all IVDs must comply with upgraded IVDR postmarket surveillance requirements, and any new test or test with a “significant change” will need an IVDR certificate to be placed on the market. Check out our latest Market Pathways’ Scorecard infographic, with a rundown of compliance timelines and a snapshot of the IVDR state of play.
