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Contact:
Wanda Moebius
202-434-7240
wmoebius@advamed.org
February 12, 2016

EU and US Medical Technology Industry Welcomes Progress and Renews Call for Regulatory Cooperation in T-TIP

Brussels/Washington - As negotiations for the Transatlantic Trade and Investment Partnership (T-TIP) enter their third year, the medical technology industry on both sides of the Atlantic - represented by AdvaMed, COCIR, EDMA, Eucomed, and MITA - thanks both governments for their hard work and urges negotiators to solidify their commitment to regulatory cooperation. The group renews its call for cooperation on medical device regulations in three high-priority areas: 1) a single audit for medical device quality management systems, 2) harmonized implementation of unique device identification (UDI), and 3) a single unified format and structure that enables simultaneous product submissions (Regulated Product Submissions, or RPS) to multiple regulators electronically. Our group seeks commitments to specific objectives in each area:

MDSAP - Full implementation, within a reasonable and specified timeframe, of the Medical Device Single Audit Program (MDSAP) developed by the International Medical Device Regulators Forum. MDSAP, if implemented appropriately, would conserve regulatory resources, save industry costs, and continue to facilitate patient access to safe and innovative medical technology.

UDI - Implementation of compatible device identifier systems on both sides of the Atlantic which enable effective regulatory data exchange and simplification of the related regulatory processes. 

RPS - Implementation of a single unified format and structure for a system that enables simultaneous submissions to multiple regulators electronically, improving the efficiency of submissions and reducing time to market.

Further details of these proposals were outlined in our recommendations to both governments in 2013.

Regulatory cooperation in all three areas embodies the core regulatory principles of T-TIP for medical technology by eliminating duplicative practices and converging similar systems in a way that benefits businesses and patients alike, without compromising safety.

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