EFORT Position on Revision of the Medical Device Regulation

The European Federation of National Associations of Orthopaedics and Traumatology (EFORT) welcomes the European Commission’s proposal 2025/0404 (COD) for a targeted evaluation and revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). EFORT, representing 41 National Orthopaedic and Traumatology Societies accross Europe, and by this more than 60.000 clinical active orthopaedic […]

BioMed Alliance shares new set of recommendations on key challenges in system for medical devices & IVDs

The BioMed Alliance in Europe represents medical societies at the European level. It is active to voice the concerns and expectations of medical specialists and raise awareness on the need to involve healthcare professionals in ongoing health-related issues. EFORT is an active member of the Biomed Alliance and has been contributing to several initiatives on […]

How has EFORT contributed to the implementation of the Medical Device Regulation through CORE-MD?

Between April 2021 and March 2024, EFORT has been involved as co-leader in an EU-funded project called CORE-MD. CORE–MD objectives were to systematically review methodologies for the clinical investigation of high-risk medical devices (Work Package 1), recommend how new trial designs can contribute (Work Package 2), and advise on methods for aggregating real-world data from […]

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