US manufacturers face high costs under MRA (mutual recognition agreement) with Europe
This article was originally published in Clinica
Executive Summary
US manufacturers may have to pay over twice as much as their European counterparts to have their devices assessed under the mutual recognition agreement (MRA) between the EU and the US. The FDA's Devices and Diagnostics Letter suggests that the FDA is considering reimbursing US companies for the additional costs, otherwise there may be little incentive for them to use the testing laboratories designated under the MRA as conformity assessment bodies (CABs). Under the MRA, European companies can use a CAB in Europe trained to test to US requirements for products intended for the US market, while US firms can use CABs in the US trained to test to EU requirements.