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I run a medical device manufacturing company. Recently, in order to export to Germany, I am considering concluding an export contract with a company in Germany, and people around me strongly recommend that I have a legal review of the contract. Please tell me whether I really need to have the contract reviewed and, if so, where and how to have it done.
legal review of a contract
Answer
Published:
Author : Kuk Il KIM
Hello. This is an attorney experienced in corporate law at Daeryun Law LLC.
If you operate a medical device manufacturing business and are planning to export overseas, a legal review of the contract is essential.
This is because, in particular, when the counterparty is a foreign corporation, as in the case of Germany, you must go beyond mere language translation and diagnose the legal risks of the contract structure itself.
If the contract contains no indication regarding the governing law, then when a dispute later arises you may have to go to a German court and German law may apply.
Such a clause can pose a risk of tens of millions of won or more to a company.
Furthermore, even in the case of an English-language contract, entirely different legal effects can arise depending on interpretation.
Since a single word or a single sentence structure can completely change a company's profit structure or its ability to respond to disputes, you must have a legal review of the contract conducted.
For medical devices, not only the domestic Medical Devices Act but also international regulations and licensing requirements, such as the EU CE certification and the German medical device regulation (MDR), must be reflected in the contract.
For example, if matters such as CE certification requirements, the use of clinical trial data, and the scope of quality assurance and liability are not specified in the contract, the export contract itself may be delayed or may face legal disputes.
A contract between companies is a legal act.
Therefore, advice on a contract must be performed by an attorney with expertise in law.
In particular, when exporting to an EU country such as Germany, you must go beyond simple translation and review together international contract practices, German local laws and regulations, EU medical device regulations (CE certification, RA approval), and the domestic Medical Devices Act.
If these are not reflected, a company may suffer significant losses regarding the interpretation of contract terms, the scope of liability, and recall and quality issues.
Daeryun Law LLC's advisory approach is as follows.
✅ Analysis of the draft contract and diagnosis of risks by clause
✅ Comparative analysis of German local law and domestic regulations
✅ Revising the counterparty's proposal and drafting responsive language
✅ Redesigning the structure in preparation for the possibility of future disputes
✅ Reviewing interpretation differences between the translation and the original text
For specialized industries such as medical devices, an attorney experienced in corporate law and an attorney experienced in medical cases jointly analyze the contract and provide verified advisory services.
A legal review before concluding a contract is, ultimately, a mechanism for securing a company's ability to survive in the event of a dispute.
If you would like to proceed with a legal review of a contract, you may wish to submit a consultation request to our firm.

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