Pre-Market Authorization And Other Sweeping Proposals Unveiled In EU Parliament

A key legislator on device reform in the European Parliament has issued a strong call to establish pre-market authorization for high-risk devices in Europe, among other consequential regulatory changes.

High-risk medical devices would for the first time be subject to a government pre-market authorization process before being allowed to launch in the European Union under a proposal issued April 12 by a key legislator in the EU Parliament.

The proposal comes from Dagmar Roth-Behrendt of Germany, who was designated rapporteur, or liaison, for medical device reform legislation in the Parliament’s Public Health, Environment and Food Safety Committee. The...

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