EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5. - Cobbaert C; Neumaier M; Capoluongo E; Mullier F; Orth M; Streichert T; Bhattoa HP; Bossuyt P; Barbosa LB; Plebani M; Zima T (Clinical chemistry and laboratory medicine, 2026)