No justification to recast European medical device directives, say AdvaMed and European groups

Published: 07/14

WASHINGTON, DC, USA - (HealthTech Wire) - The Advanced Medical Technology Association (AdvaMed) has joined seven leading European industry organizations in expressing concern with the recently proposed European Commission recast of the Medical Device Directives (MDDs).

AdvaMed joined COCIR, EUCOMED, EDMA, EHIMA, EUROMCONTACT, EUROM VI and FIDE – which represent 95 percent of the European medical technology community -- in this effort. Read the full position of the European associations here. “There is no need for an overhaul of the MDDs now,” said Stephen J. Ubl, president and CEO of AdvaMed. “The current European model for approving medical devices is among the world’s best and provides patients timely access to safe and innovative medical technology,” he said.

“AdvaMed commends the European Commission for examining ways to strengthen the safety of its regulatory system for medical devices,” said Ubl. The impact of the changes introduced last year in the new European Directive 2007/47/EC still need to be assessed. Rather than recasting, AdvaMed encourages the European Commission to work within its existing structure to strengthen the Competent Authorities and Notified Bodies and ensure consistent application of the Directives by Member States.

The European medical technology community and AdvaMed agree that there is no need to create a centralized European agency for Medical Devices that would take on an oversight role for the medical technology sector. Instead, we believe the oversight concerns raised by the European Commission can be addressed through improved implementation of existing measures such as the use of the European Database on Medical Devices which has been under development for several years.

AdvaMed also believes that any proposed revision of the MDD should ensure the adoption of the Global Harmonization Task Force (GHTF) regulatory model.