Simplification of EU digital legislation: MedTech Europe proposal to ensure coherent implementation

Digitalisation is reshaping how healthcare is delivered, and medical technologies are at the centre of this shift. Digital medical technologies, including connected devices, diagnostic software, and AI-enabled solutions, are key in supporting earlier diagnosis, remote monitoring, and personalised treatment.

In this position paper, MedTech Europe outlines our vision for a digital policy framework that supports innovation while remaining aligned with existing sectoral legislation, such as the In Vitro Diagnostic Medical Devices Regulation (IVDR), Medical Devices Regulation (MDR), and the European Health Data Space (EHDS) Regulation. A mind-shift towards regulation simplification is urgently needed.

In this paper, we propose key recommendations to ensure that medical technologies are safe and effective, while avoiding duplicative or conflicting obligations that would create unnecessary complexity and regulatory and administrative burden.

MedTech Europe remains committed to working with EU policymakers to ensure that digital legislation is fit for purpose, supports innovation and strengthens patient care.

Read our position paper on the simplification of EU digital legislation.