Pre-market charges for medical device firms

Medical devices firms will be forced to pay significant pre-market “risk assessment” charges if they want to sell their products under new patient safety laws.

Pre-market charges for medical device firms

The Irish Medicines Board wants the Government to impose the rule change by 2015 to prevent another DePuy hips or PIPs breast implant crisis — and ensure the public does not have to pay to resolve future problems.

Speaking at an Oireachtas Health Committee meeting, the independent watchdog’s chief executive, Pat O’Mahony, said the controversies — which damaged thousands of patients in Ireland — must not be repeated.

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