Surprise Inspections, And More, Coming Soon To The EU
This article was originally published in The Gray Sheet
Executive Summary
It will be years before the device and diagnostic regulations proposed last month by the European Commission take effect, but policymakers are pressing forward to implement select reforms, including surprise facility inspections, on an interim basis by early next year.
You may also be interested in...
EU “Trialogue” On Device Reforms Could Happen By Early Next Year
Representatives of the three segments of the European Union government, the Parliament, Council and Commission, may begin formal talks on final legislative language to reform device and diagnostics regulations at the end of this year or early next year, according to the outgoing Greek presidency of the Council.
Regulatory News In Brief
IMDRF releases three new proposed guidance documents. FDA is accepting comments on its plans to accept electronic submissions for device recalls. More regulatory news.
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.