Document New medtech regulations Orthopaedic

Statement with EFORT on cobalt in orthopaedic implants

MedTech Europe’s Orthopaedic Sector Group adopted a joint statement with EFORT, the European Federation of National Associations of Orthopaedics and Traumatology, on the use of cobalt in orthopaedic implants.

Under the new EU Medical Devices Regulation 745/2017, various medical devices that continue containing cobalt will very likely need to comply with new obligations – notably, they will need to indicate on the device or label that cobalt (a purportedly ‘cancer-causing’ substance) is present.

The statement aims at reassuring patients and healthcare professionals that the presence of cobalt in these implants – and the communication of this on the device/label – is no cause for safety concerns, and does not change these products’ long history of safe clinical use.

Posted on 04.10.2018

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