As announced in our previous post, the rapporteur (i.e., the leader of the parliamentary process) for the new Regulation on medical devices, Mrs. Dagmar ROTH-BEHRENDT, has proposed the introduction of a pharma-like pre-marketing authorization regime for high risk medical devices in the EU.
In her recent report submitted to the ENVI Committee of the European Parliament (the parliamentary committee in charge of environmental and public health issues), Mrs. Dagmar ROTH-BEHRENDT criticizes the conformity assessment procedure involving notified bodies for high risk devices and proposes the creation of two types of marketing authorization procedures for those devices. The authorization process would either be centralized (i.e., at EU level) for innovative devices, or decentralized (i.e., at national level) for other devices. However, manufacturers required to use the decentralized procedure would have the possibility to apply for the centralized procedure.
Continue Reading Lead Member of the European Parliament Proposes a Pre-Marketing Authorization System