Specialists in Dangerous Goods Law for the Medical Technology Sector

For manufacturers, exporters and importers of medical devices: We ensure your supply chains comply with dangerous goods regulations – legally sound, practical and globally aligned.

Why Dangerous Goods Law Matters to MedTech Companies

Many medical devices contain components that are subject to international dangerous goods regulations (ADR, IATA, IMDG, etc.):

• Lithium batteries in diagnostic and portable medical devices
• Chemicals in test kits, reagents and laboratory supplies
• Pressurised gas containers and aerosols in surgical instruments
• Radioactive substances used in imaging technologies

Errors in classification, packaging, labelling or documentation can result in fines, delivery delays or liability risks – both nationally and internationally.

Our Services for Your Dangerous Goods Compliance

Product Classification & Transport Approval

• Assessment of whether and how your medical device qualifies as a dangerous good
• Support with UN classification and applicable exemptions
• Liaison with notified bodies and regulatory authorities

Legally Compliant Shipping Preparation

• Drafting and review of safety data sheets and transport documents
• Packaging and labelling requirements
• Advice on modes of transport (air, sea, road)

Export & Third Country Compliance

• Guidance on IATA-DGR, IMDG Code and other international frameworks
• Support with customs classifications and embargo regulations
• Legal assistance with product registrations abroad

Defence and Legal Representation

• Support in regulatory proceedings (Customs, Federal Aviation Authority, BAM)
• Legal defence in cases of non-compliance or product recalls
• Contract review concerning dangerous goods responsibilities and Incoterms

Training for Your Team

• Legally mandated staff training sessions
• Dangerous goods basics for shipping and product development teams
• Training certificates for regulatory compliance

Who We Advise

Our services are tailored to:

• Manufacturers and developers of medical devices and IVDs
• Exporters and importers with global MedTech supply chains
• MedTech start-ups seeking regulatory certainty as they scale

Case Study – Diagnostic Kit Containing Ethanol

A diagnostics company plans to ship a kit containing ethanol-based reagents by air.
We review the UN classification, identify applicable exemptions (e.g. limited quantities), prepare compliant shipping documents, and advise on packaging, labelling and air transport requirements under the IATA-DGR.

Why Are Batteries in Medical Devices a Dangerous Goods Issue?

Lithium batteries – particularly lithium-ion (rechargeable) and lithium-metal batteries (non-rechargeable) – are essential components in modern medical devices. They are used in a wide range of equipment, including:

• Portable defibrillators
• Insulin pumps
• Mobile monitoring systems
• Infusion devices
• Portable imaging equipment

What many are unaware of: Under transport law, lithium batteries are classified as dangerous goods. This means they are subject to specific requirements under the following international regulations:

• ADR (road transport)
• IATA-DGR (air transport)
• IMDG Code (sea freight)