US tariffs on medical devices: What manufacturers need to consider now

Customs break with limited benefits

The announced tariff pause is limited in time and therefore does not create any reliable planning security. For European manufacturers who export to the US market, the question is: what happens after the 90 days?

Important points:

• The new universal duty rate of 10% is only temporary.

• Existing additional tariffs - around 25% on steel and aluminum components - remain in place.

• Many supplier parts for medical devices continue to be subject to these specific duties.

• Contracts already concluded with fixed prices are coming under pressure because higher import costs can no longer be absorbed.

This can significantly reduce margins, especially for high-quality products whose components are of international origin.

Political upheaval with economic consequences

The current measure is part of a protectionist trade policy that is not primarily geared towards economic, but geopolitical interests. The consequences for the medtech industry are considerable:

• Supply chains become unstable as international imports are made more difficult.

• Planning security for medium-sized manufacturers is significantly reduced.

• The FDA is under financial pressure, which is already reflected in staff cuts and delays in approval processes.

• The combination of customs duties and regulatory uncertainty is making market access to the USA increasingly complex.

The industry association BVMed therefore clearly warns:
"Medical devices must not become part of geopolitical conflicts. Tariffs jeopardize the availability of vital products."

Who is particularly affected?

Small and medium-sized companies that produce in Europe and export to the US market are feeling the effects the most. They are often lacking:

• own branches or sales structures in the USA,

• contractual flexibility to adjust prices or delivery terms,

• internal resources for the strategic assessment of geopolitical risks.

These companies are often dependent on stable framework conditions - both in terms of regulation and in the supply chain. The combination of political volatility, rising costs and an uncertain approval situation hits them particularly hard.

Strategies for manufacturers: what to do now

MEDAGENT recommends that companies review their US market strategy in the short term and position themselves with regulatory flexibility.

In concrete terms, this means

• Analysis of product components with regard to customs-relevant materials (e.g. steel, aluminum)

• Evaluation of existing supply contracts and pricing models

• Review of the FDA approval status and adjustment of the schedule

• Gap analysis for documentation for possible re-certification or additional requirements

• Diversification of markets and distribution channels to reduce dependence on exports
  
  

How MEDAGENT supports

As an experienced partner for regulatory and strategic consulting, MEDAGENT accompanies you through this phase of uncertainty - with concrete measures and comprehensive market knowledge:

• FDA approval advice taking into account current developments

• Regulatory GAP analyses to ensure compliance

• Support in adapting QM systems to dynamic market requirements
  
  

Conclusion

The situation in the US market remains volatile - manufacturers must remain vigilant and not rely solely on short-term political measures such as the tariff pause. Strategic flexibility, regulatory robustness and proactive market monitoring are now more important than ever.

MEDAGENT will support you. Get in touch now and discuss measures before the next changes take effect.