Medical Technology in the United States

FDA approval is a distinct regulatory process with its own procedural steps, deadlines, and responsibilities—from the classification of the medical device through the respective approval process to post-market surveillance after market launch. From a legal perspective, this raises a number of questions: How are responsibilities contractually allocated between the manufacturer and its U.S. partner? What documentation requirements arise from the approval status? And how do changes to this status affect existing supplier, distribution, or collaboration agreements?

We handle these legal interfaces with FDA regulations—the approval process itself remains the responsibility of specialized regulatory affairs consultants, with whom we work closely as needed. This ensures that your contracts remain valid even if your product’s approval status changes.

Distribution agreements with U.S. distributors cover far more than just prices and territories: the allocation of liability between the manufacturer and the distributor, recall obligations in the event of a product defect, exclusivity and the scope of the contractually assigned territory, as well as termination rights, which are structured differently under U.S. law than under German law. For medical devices, there are additional regulatory obligations, such as reporting incidents or ensuring traceability.

We draft and review distribution agreements with these specific considerations in mind—including clear provisions on liability, product recalls, and termination, tailored to the regulatory requirements for your medical device.

U.S. product liability law follows different standards than German law: The burden of proof is often distributed differently, and damages awards can be significantly higher than is customary in Germany. For medical technology companies whose products are used directly on patients, this has a direct impact on insurance coverage, contract clauses, and ongoing risk management.

We identify areas where adjustments are needed compared to German law and draft contracts and clauses so that they stand up to U.S. product liability practices—in coordination with your insurer.

Patents and trademarks that are protected in Germany are not automatically valid in the U.S.—patent and trademark protection for medical devices must be applied for and enforced separately for the U.S. market. This also applies to the question of how to deal with competitors and potential infringers in the U.S., for example, in the context of cease-and-desist letters or infringement proceedings.

We support your medical device’s IP strategy in the U.S. context—from filing and monitoring to taking action against infringers—in collaboration with our colleagues in New York, Boston, and San Francisco.