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.

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

Our Law Firm App: Legal Expertise – Clear, Concise and Industry-Focused
app.anwaltskanzlei-jakob.com

With our exclusive law firm app, you gain access to clearly presented explainer videos, podcasts, and regularly updated features covering recent court decisions, legislative changes and new regulations – all specifically tailored to the needs of the medical technology sector.