Navigating Trump Tariffs, ISO 13485 Harmonization, and MDR Challenges: Global Insights for the Medical Device Industry

The in2being team recently attended MEDICA, one of the largest medical device trade fairs in the world, held from November 11–14 in Düsseldorf, Germany. Amidst the aftermath of the unexpectedly pivotal U.S. presidential election, we stepped into a rapidly evolving international landscape marked by potential disruptions and opportunities for the medical device industry.

We’re working on a MedTech Crossroads episode of interviews with colleagues on both sides of the pond, but we wanted to summarize some of the most salient points here for you fresh from Germany.

European companies are grappling with the ongoing challenges of implementing the Medical Device Regulation (MDR). Much of the current difficulty stems from the notified bodies—the commercial entities tasked with auditing compliance—struggling to manage the increased workload. As a result, costs have surged, timelines have stretched, and there is a looming risk of shortages for medical devices already on the market. Notably, the MDR affects both new devices and those already in use, requiring existing products to undergo re-certification to remain available.

The proposed Trump tariffs introduce significant uncertainty for the medical device industry. While much remains speculative, certain implications are clear: U.S. manufacturers reliant on foreign components could face higher costs and delays due to the need for re-verification when components change. Tariffs do sometimes exempt certain categories, and medical devices MAY be included, but certainly this could be a motivation for foreign companies to bring their final production to the US. A common refrain we heard was “it’s too early to tell” and “focus on the basics and on minimizing the length of your supply chain.” If there’s one thing COVID taught us, it’s that shorter supply chains are useful, even in a globalized economy.

There is promising news for both U.S. and European medical device companies. The FDA’s anticipated adoption of ISO 13485 by reference to replace much of the current cGMP framework is expected to impose minimal compliance burdens. While U.S. companies will need to meet the February 2026 implementation deadline, the transition should be straightforward for organizations already following ISO 13485 and not insurmountable for those following 820. This change also benefits European companies considering U.S. operations, as many are already compliant with this globally recognized standard.

If you have questions about how these global regulatory and trade developments might impact your medical device strategy, we’re here to help. Stay tuned for an upcoming MedTech Crossroads episode featuring insights from industry experts on both sides of the Atlantic.
 

If you have any questions, please feel free to reach out for more insights!