ARTICLE SUMMARY:
In this week’s Pathways Picks: Important inflection points for future medtech regulatory reforms with EU Parliament elections and a notable committee hearing in Germany; US lawmakers press CMS on digital therapeutics reimbursement; lab industry follows through on LDT lawsuit; FDA completes reorganization; Brazil regulatory agencies face budget cuts; and more from the US, Europe, and China.
EU Reform Picks
This week’s elections and a path to fundamental medtech reforms:
Parliamentary elections. EU citizens are going to the polls this week, June 6-9, to vote on European Parliament candidates, with important implications for the direction and speed of potential reforms to medtech regulations. As efforts to reassess and consider fundamental changes to the Medical Device and IVD Regulations build in momentum, the new Parliament will almost certainly be voting on MDR/IVDR-related legislation sometime during its upcoming five-year term.
