Thought leadership

Medical Device Regulation 2.0: Why stakeholder disagreement is bad for all

2026-06-29T11:16:00+01:00By John Wilkinson OBE

Proposals for MDR 2.0, published in December 2025, have exposed deep divisions across the EU medical devices community. This thought leadership article argues that, without genuine stakeholder consensus and structural reform, history risks repeating itself, with serious consequences for patients and industry alike.