MEDTECH NEWS

Data produced by ‘Off-Label’ Device Use in accordance with EU Medical Device Regulation 2017/745


October 13, 2022

The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs via CIRCABC. It has received approval from the Team-NB general assembly.

Off-label usage is addressed in the Medical Device Regulation (MDR) in Annex XIV Part B, but it is not defined there. Manufacturers are expected to proactively discover misuse or off-label uses of their products through PMCF operations.

Many definitions related to pharmaceuticals can be found by searching “off-label usage definition,” however few definitions particularly related to medical devices can be found. Off-label usage, however, might be interpreted broadly speaking.


Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.


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