Influential European Parliament committee unanimously supports tighter PMA-led medtech regulatory regime
This article was originally published in SRA
Executive Summary
The European Parliament's influential environment and public health committee has called for a shift to a pre-market authorisation system for some high risk-devices. The demand is included in a resolution unanimously adopted by the committee and intended to influence European Commission thinking on the proposed revision of the medical device directives that is under way1.
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