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One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness.  While I’d love to claim the same for all other essential elements of the new regulatory system, progress […]

We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]