Lawyer for Medical Technology
MedTech LAW-ImEx
Legal & Regulatory MedTech Consulting – with International Expertise
Law Meets Technology
Are you developing, distributing, importing, or exporting medical devices or diagnostic/therapeutic technologies? As an experienced lawyer, I support you in bringing your products safely, compliantly, and efficiently to market—whether in Germany, the EU, or globally.
We combine legal expertise with product understanding and years of experience. At Jakob Law, we accompany your project from the initial idea to successful market launch. We also assist with individual phases, such as contract drafting, implementing import/export procedures, or creating bespoke software solutions.
Pilot companies wanted – help shape the future of medtech compliance!
The digitization of legal processes opens up enormous potential for companies – especially in the international trade of medical devices, where regulatory requirements are constantly increasing. With JAKOB LegalTec, we are developing a software solution that integrates all legally relevant checks into the international trade process – from sanctions list checks and export controls, MDR/IVDR regulatory requirements, and customs issues to contract drafting.
Our Services – For Projects with the Highest Standards
Market Access & Product Approval
- Advice on Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), Medical Devices Implementation Act (MPDG), CE marking, technical documentation, and standards (e.g., ISO 13485:2016)
- Support with UDI/EUDAMED, declarations of conformity, and audits
- EU market-entry strategies for international manufacturers and distributors (including EU Authorized Representative)
- Product responsibility within the context of the circular economy
Contract & Distribution Law
- Drafting and reviewing supply, OEM, and distribution agreements (including Incoterms® and CISG)
- Designing and negotiating non-disclosure agreements (NDAs) and EU-AR contracts
- Developing international distribution strategies and partnerships
- Product liability, recall management, and warranty clause optimization
- Risk mitigation for international transport
Customs & Export Control
- Tariff classification, rules of origin, import/export handling
- Export control law (including goods-list review), BAFA export license applications, and sanctions screening
- Support during international audits and regulatory inquiries
- MedTech-specific dangerous goodstransport (ADR, RID, IMDG, IATA for batteries, radioactive materials, infectious substances, etc.)
In collaboration with highly specialised interdisciplinary partners—including engineers, technicians, software developers, compliance managers, chemists, and expert translators from our network—our legal expertise can be efficiently integrated into other areas when required. This includes, for example, software development, technical assessments, technical documentation, and compliance management.
Compliance & Supply Chain Law
- Identifying and assessing compliance risks
- Developing and implementing Compliance Management Systems (CMS), including LkSG
- Supply chain risk management (e.g., EN ISO 14971:2019 standards)
Software & Regulatory Tech
- Developing software modules for risk management, labeling, compliance, export control, distribution, and EUDAMED integration
- Building digital distribution tools and interfaces (e.g., customs portals, distributor systems, ERP integrations)
- Creating robust NDAs for technology discussions
- Advising on risk related to MPDG violations (e.g., misclassification, unclear intended use)
- Export control for software and technology transfers
Technical Documentation & Translations
- Advice on labels, IFUs (Instructions for Use), and technical documentation
- Coordination of multilingual technical translations for international markets
Your contact person
Lawyer Inés Jakob
& Certified Dangerous Goods Safety Adviser
Please send us a short email with your request to:
Or arrange immediately a free, non-binding introductory meeting using the following link:
Please note that, as an international business law firm, we do not take on private client matters.
We welcome your enquiry and are happy to assist!
Pilot companies wanted – help shape the future of medtech compliance!
The digitization of legal processes opens up enormous potential for companies – especially in the international trade of medical devices, where regulatory requirements are constantly increasing. With JAKOB LegalTec, we are developing a software solution that integrates all legally relevant checks into the international trade process – from sanctions list checks and export controls, MDR/IVDR regulatory requirements, and customs issues to contract drafting.
Market Access for MedTech Products in the EU
Import Requirements for Medical Devices
Federal Court of Justice Ruling Brings Clarity on Design Defects and Safety Expectation
BFH on the Customs Classification of Combined Machines
General Court declares Commission decision on “Inhaler Broncho-Air®” invalid
Why We’re the Right Firm for Your Project:
Specialised and experienced: Customs law, international trade, and international sales law are at the core of our legal practice.
Where law meets technology: We understand not only the legal framework, but also the technical details of your products.
Digital and international: Innovative legal solutions, global consultancy, and practical, transparent support for your operations.
Collaboration and efficiency: Lawyers, engineers, and software developers work together to deliver tailored, functional solutions.
