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Dear Experts,
Our devices contain a component (not patient contacting directly/indirectly) that contain and CMR/ED SVHC above 0.1% w/w.
We identified an alternative and have been planning implementation in two months time. However this week the new component has just failed accelerated aging. This leaves us in an impossible situation where we will need to follow the SCHEER guidance and perform a benefit risk assessment in order to obtain a CE mark under MDR as we don't have time to address and re-age the component.
We need a consultancy to support in the BRA from a toxicological, material science (polymer) and clinical perspective.
Advice and recommendations needed please!