EU Negotiators Make Headway Toward New Device ‘Scrutiny’ Mechanism
This article was originally published in The Gray Sheet
The three power centers in the European Union government have come close to alignment on a plan for a more centralized premarket "scrutiny" mechanism for medical devices in ongoing talks, according to sources. The same progress has apparently not been made for in vitro diagnostics yet.
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Device and diagnostics companies could get a look at the future regulatory realties in Europe as soon as August if EU policy-makers maintain current progress on negotiating new broad-reaching regulations.
Sources close to ongoing talks on European regulatory reforms say it's possible that policy-makers could decide to drop sections of proposed regulations addressing EU-wide policies for single-use device reprocessing to speed the overall path to resolution.
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.