As an active member, EFORT has been contributing to initiatives on medical devices, including a recent survey to assess challenges faced by Orthopaedic and Traumatology surgeons. EFORT also participated in the European Commission’s workshop (Brussels, 20 March 2025) to provide input on the implementation of the Medical Device Regulation.
In March 2025, BioMed Alliance published a report identifying major obstacles in the application of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Key concerns include high certification costs, limited access to essential devices, regulatory complexity, and barriers to innovation.
To address these issues, the Alliance calls on EU policymakers to streamline certification processes, strengthen regulatory coordination, improve market access, and foster medical innovation. Greater transparency and stakeholder engagement are also essential to ensure a sustainable and effective regulatory framework.
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