Press Release: Restoring confidence in medical devices. Action Plan after the PIP scandal tightened control in Europe

The EPSCO Council has discussed on the 20 June 2014 the joint actions taken by the European Commission and the Member States to restore confidence following the scandal of defective breast implants produced by the French PIP company. These measures were included in the Joint Plan for Immediate Actions under the existing Medical Devices legislation (the so-called PIP Joint Action Plan) agreed in 2012.

The PIP scandal made it clear that immediate improvements in the oversight of medical devices were needed. This is why the European Commission and Member States agreed on an Action Plan aiming at improving the control on the basis of existing legislation. It focuses on four key areas: the functioning of notified bodies; market surveillance; coordination in the fields of vigilance; communication and transparency.

European Commission: DG Health & Consumers: Public health: Medical devices http://ec.europa.eu/health/medical-devices/index_en.htm

ESO: Background Information: Medical devices: European Commission calls for immediate actions - tighten controls, increase surveillance, restore confidence http://www.europeansources.info/record/press-release-medical-devices-european-commission-calls-for-immediate-actions-tighten-controls-increase-surveillance-restore-confidence/

ESO: Background information: Breast implant fears spark Brussels crackdown http://www.europeansources.info/record/breast-implant-fears-spark-brussels-crackdown/

ESO: Background information: Safer, more effective and innovative medical devices http://www.europeansources.info/record/press-release-safer-more-effective-and-innovative-medical-devices/

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