EU – USA Cooperation in Medical Devices

During President Juncker’s visit to the White House on 25 July 2019, he stated in a press conference that the EU is currently working to reduce barriers and increase trade in medical products.

The industry of medical devices is dominated by the EU and US together. While the US’s total sales represent 43% of the global market, making it the world leader in the medical devices industry, the EU total sales amount to 29%. Japan and China occupy the 3rd and, respectively, the 4th place in this rank.

Medical devices from the U.S. represent over 55% of all devices imported to the EU, making the US the main supplier of medical devices to the EU. Also, in 2017, the U.S. exports to the EU were of €15.7 billion, while the EU exports to the U.S. stood at €16.6 billion.

However, both the US and EU have stern rules for medical devices and sometimes these rules require that the same device is tested twice.

Even if the EU and the U.S. rely mainly on the same international ISO standards, which is lowering the adaptation costs for industry, the approval and inspections systems differ, leading to double controls in pre-market product approvals and controls of manufacturing sites.

Consequently, in order to reduce costs for manufacturers, the EU and US regulators are collaborating to ensure that conformity assessment bodies on both sides follow approximately the same procedures and recognize each other’s work as much as possible – to avoid duplication of controls.

The cooperation in these aspects will not only maintain their current position as industry leaders, but it will make it easier for medical device producers to export their product and for patients to access and use the medical devices they need.

Bianca Sofian

RA Department

September 9, 2019

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