Zum Inhalt springen
IndustryUpdated October 15, 2025

Medical devices — requirements, equipment, compliance

Medical devices range from consumables to MRI scanners.

Medical devices range from consumables to MRI scanners. Often high value, sensitive, frequently with cold-chain requirements for implants/IVD reagents, and critical delivery windows for hospital projects.

Typical Incoterm
DAP oder CIP
Regulations
MDR 2017/745, IVDR 2017/746, ISO 13485, CE certificate, Eudamed, Unique Device Identification (UDI).

01Why Medical devices needs specialised logistics

Medical devices range from consumables to MRI scanners. Often high value, sensitive, frequently with cold-chain requirements for implants/IVD reagents, and critical delivery windows for hospital projects.

Requirements differ significantly from standard LCL logistics: different documents, different equipment, different safety standards.

02Typical goods and trade flows

Main commodities: Implants, instruments, imaging systems, IVD reagents, sterile goods.

Flows usually go from a small number of production and raw-material sources to global distribution centres. Transit time, frequency and capacity booking are therefore critical.

03Equipment and packaging

Clinical-sterile packaging, wooden crates for large equipment, temperature-controlled boxes, shock protection.

Equipment choice directly affects transport cost, CO₂ footprint and damage rate. Recommendation: agree an equipment concept with the carrier before requesting the first quote.

04Compliance and regulatory framework

Key frameworks: MDR 2017/745, IVDR 2017/746, ISO 13485, CE certificate, Eudamed, Unique Device Identification (UDI).

Beyond those, industry-specific certificates and audits (e.g. supplier audits, AEO, TAPA) are typically prerequisites for market access.

Frequently asked questions

Which Incoterm should I use for Medical devices?

In practice, DAP oder CIP is the industry default. The final choice depends on country, sales model and tax situation — always have the term reviewed by customs and tax advisers before contract.

Which regulations are most critical?

The frameworks named above — particularly MDR 2017/745, IVDR 2017/746 — should be embedded in your SOPs and audit programme.

Topics

MedizintechnikMDRIVDRUDIImplantateKlinik

Further resources