MedTech Europe renews call for regulatory cooperation on TTIP

Posted on 07.04.2016

The EU/US Transatlantic Trade and Investment Partnership (TTIP) 12th round of formal negotiations was held in Brussels during the week of 22 February. Within its framework, the transatlantic medical technology associations (AdvaMed, COCIR, EDMA, Eucomed, and MITA) renewed their call for regulatory cooperation in the three key areas that were proposed at the start of the talks three years ago.

These are: 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.

A joint statement was released prior to the start of negotiations. The 13th round is scheduled for April 2016.

MedTech Europe remains committed to the TTIP process in conjunction with AdvaMed in the US in order to ensure that patients and the medical technology sector benefits from this landmark trade agreement.