Medical technology in the USA
Law at the interface with FDA regulations, working with US lawyers in Munich
Your medical device is to be marketed in the US; you have an American distributor lined up, or you have received initial enquiries from the US market – and this raises the question of how contracts, liability and compliance with FDA regulations can be legally safeguarded.
German medical technology companies operate in a highly regulated environment in the US. We advise you on the legal aspects of entering this market – whilst the approval process itself remains the responsibility of specialist regulatory affairs consultants, our US lawyers in Munich will assist you with contracts, liability and distribution.
Challenges
In the US, medical devices are subject to a separate regulatory process, which entails its own deadlines, responsibilities and documentation requirements. Anyone who underestimates this interface between regulatory approval and contract drafting risks entering into contracts that are tailored to a regulatory status which may change.
US distributors, investors and business partners expect contracts that govern liability, recall obligations and exclusivity in accordance with US standards – German model contracts often fall short in this respect.
Solutions
We provide guidance on the legal aspects relating to FDA regulations – responsibilities, documentation requirements and the impact of changes in marketing authorisation status on existing contracts – without advising on the marketing authorisation itself.
We draft distribution agreements, liability clauses and recall procedures in strict accordance with US standards. Where regulatory requirements for medical devices apply, we work closely with your regulatory advisers.
Let’s talk about your entry into the US market.
Whether it’s a distribution agreement, product liability or the protection of your intellectual property: during the initial consultation, we will clarify which legal issues arise in connection with your US project as a medical technology company and how contracts and organisational structures relate to FDA regulations. You’ll be speaking directly with our US lawyers in Munich – whilst we do not advise on the approval process itself, we’ll bring in our colleagues from New York, Boston or San Francisco as and when required.
Our services
Four key elements for the legal aspects of your US operations as a medical technology company – from compliance with FDA regulations, through distribution agreements and product liability, to the protection of your intellectual property. All four follow the same principle: contracts and structures that are valid under US law and provide legal protection for your product on the US market.
Legal interfaces with FDA regulations
FDA authorisation is a standalone regulatory process with its own procedural steps, deadlines and responsibilities – ranging from the classification of the medical device through the relevant authorisation procedure to post-market surveillance following market launch. From a legal perspective, this raises a number of questions: How are responsibilities contractually allocated between the manufacturer and the US partner? What documentation requirements arise from the approval status? And how do changes to this status affect existing supplier, distribution or cooperation agreements?
We manage these legal interfaces with FDA regulations – the authorisation process itself remains the responsibility of specialist regulatory affairs consultants, with whom we work closely when necessary. This ensures that your contracts remain valid even if the authorisation status of your product changes.
Distribution agreements with US partners
Distribution agreements with US 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 allocated territory, as well as termination rights, which are structured differently under US law than under German law. In the case of medical devices, there are additional regulatory obligations, such as the reporting of incidents or traceability requirements.
We draft and review distribution agreements with these specific features in mind – including clear provisions on liability, product recalls and termination, tailored to the regulatory requirements for your medical device.
Product liability under US law
US product liability law operates according to different standards to 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 cover, contract clauses and day-to-day risk management.
We highlight areas where adjustments are needed compared with German law, and draft contracts and clauses in such a way that they stand up to US product liability practice – in consultation with your insurer.
Intellectual property in the US market
Patents and trade marks that are protected in Germany do not automatically apply in the USA – patent and trade mark protection for medical devices must be applied for and enforced separately for the US market. This also applies to the question of how to deal with competitors and potential copycats in the US, for example in the context of cease-and-desist letters or infringement proceedings.
We support the IP strategy for your medical device in the US – from filing applications through to monitoring and taking action against counterfeiters – in collaboration with our colleagues in New York, Boston and San Francisco.
Frequently Asked Questions
No, FDA authorisation itself is the responsibility of specialist regulatory affairs consultants. We provide support with the legal aspects involved – such as contracts, responsibilities and documentation requirements arising from the authorisation status.
Key factors include the allocation of liability, recall obligations, exclusivity and termination rights, which are governed differently under US law than under German contract law. In the case of medical devices, there are additional regulatory obligations that should be taken into account in the contract.
Yes, particularly where the burden of proof and compensation for damages are concerned, different standards apply in the USA than in Germany. For medical devices used on patients, this has a direct impact on insurance cover and the drafting of contracts.
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