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EU Parliament’s Public Health Committee Debates Device Reform Proposal

Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.

The European Union Parliament’s Public Health Committee debated April 24 a sweeping proposal to reform medical device regulation, including establishing pre-market approval processes for high-risk devices. Members of the committee appeared split on the question of centralized pre-market authorization, but generally supported other proposals in a committee report issued earlier this month.

The proposal was generated by Dagmar Roth-Behrendt, a parliamentarian from Germany who has been designated by the Environment, Public Health...

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