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Joint European Medical Device Industry Statement on European Medical Device Regulatory Regime

Brussels, 13 February 2012 - The European medical device technology industry associations strongly condemn the alleged fraudulent behavior of the French company Poly Implant Prothèse (PIP). Patient safety, public confidence, and ethical behavior should always be the top priorities of any organisation active in the healthcare industry.

Industry appreciates the European Commission’s swift reaction and clear proposal for a joint plan of immediate measures to strengthen the European medical devices legislation. After analysing the Commission’s proposal, industry believes the measures are balanced and appropriate and will have a positive effect on patient safety.

Industry recognises the need to improve the effectiveness of the current European regulatory framework for medical device and is ready to help providing practical suggestions on improved concepts as well as on proper implementation of the ongoing Revision of the Medical Devices Directives.

For further information please contact:
Eucomed: John Brennan - john.brennan@eucomed.org
COCIR: Nicole Denjoy - denjoy@cocir.org
EDMA: Jesus Rueda - j.rueda@edma-ivd.be
EUROMVI: Anne Hermeneit - hermeneit@spectaris.de
EUROMCONTACT: Anne-Marie Wolters - info@euromcontact.org

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