EC Cites Regulatory Controls for Medical Devices as US-EU Trade Barriers

After the US requested a three-year delay to the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) last month, the European Commission (EC) released a document identifying two types of divergent regulatory controls in the US and the EU as barriers to trade.
 
The US urged the delay to “allow for US exporters to adapt to the new requirements,” but the EU had earlier stated to a World Trade Organization (WTO) committee that “there are no grounds for the time being” to amend the transitional periods of the new regulations.
 
In the 25 July document, the EC touts “a balanced trade between the US and the EU that is a real win-win” and a less than 10% difference in trade flow. The EC adds that the US is the EU’s main medical device supplier, representing more than 55% of all medical devices imported to the EU.
 
The EC also points to both countries’ reliance on the same International Organization for Standardization (ISO) standards, noting this allows for “lowering adaption costs for industry and facilitating the integration of the value chain.” The globally agreed-upon standard on quality management systems—ISO 13485—is widely adopted in the US and the EU, among other countries. Industry adoption of 13485:2016 in the US versus in the EU differs in that it remains voluntary in the US at least for the time being, whereas the EU required transitioning to the revised standard by March. US regulators plan to transition from 21 CFR 820 to 13485:2016.
 
“But there is potential to do more in the area of approvals and inspections,” the EC states. “Our systems remain divergent, resulting in double controls.” Specifically, the EC points to US premarket approvals, manufacturing site controls and inspections as barriers to trade.
 
The EC lists ways to break down the barriers, writing that “EU and US regulators are working together to ensure that conformity assessment bodies on both sides follow the same procedures as much as possible, recognize each other’s work to avoid duplication of controls” as well as “engage in other trade facilitating actions, such as compatible product-identification systems.”
 
The next steps speak to new efforts to better collaborate with standards development organizations, with FDA and the EC both serving as members of the International Medical Device Regulators Forum (IMDRF). They also coincide with both countries’ transitions to their respective unique device identification (UDI) systems, following IMDRF efforts on UDI. The US and the EU pledged to cooperate on specifications for unique device identifiers earlier this year.
 
The EC’s document comes after EC President Jean-Claude Juncker’s visit to the White House last month. The US and the EU agreed on 25 July “to work together toward zero tariffs, zero non-tariff barriers and zero subsidies on non-auto industrial goods” and “to reduce barriers and increase trade in services, chemicals, pharmaceuticals, medical products, as well as soybeans.”