Update from the earlier Joint Statement of EFORT and MedTech Europe’s Orthopaedic Sector Group from the 14 August 2018.
Rolle, Switzerland, 24 August 2021
The EU Commission will, after receiving guidance from the ECHA on October 1 2021, raise the concern level for Cobalt contained in medical devices. The latter has been discussed for a long period, resulting in the EFORT – MedTech Statement of August 2018.
The concerns have arisen mainly in patients with metal-on-metal bearing joint replacements. Although the presence of cobalt and other metals, such as chromium, in orthopaedic implants generates conflicting evidence related to potentially hazardous effects in patients, EFORT takes this potential very seriously. Therefore, EFORT has taken the decision to perform clinical research on all available evidence within its “Implant & Patient Safety Initiative (IPSI)”.
We will keep you informed of our findings, but please feel free to contact us for information on the topic.
“Science is leading for better patient outcome”.
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