Medical Device: EC cites regulatory controls for medical devices as US-EU trade barriers


Medical Device: EC cites regulatory controls for medical devices as US-EU trade barriers

(Source: RAPS 2019-08-09)

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.”

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