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Storing medical devices under MDR demands more than just shelf space – it requires strict compliance, traceability and system-driven processes. In this article, we explain how logistics providers can support healthcare companies ensure constant device availability - ready to use, safe and fully MDR-compliant at the same time.
From diagnostic kits to surgical systems – medical devices come in many forms, but all share one thing: They require precise handling, careful storage and reliable delivery. Whether small-scale instruments or high-value capital equipment, they are not just inventory items – they are critical components in patient care.
At the same time, logistics teams must navigate a growing list of challenges: regulatory scrutiny, fragile supply chains, unpredictable demand, cost pressure and the ever-present threat of counterfeiting or cybersecurity risks.
In this context, warehousing becomes more than a physical location. It is a regulated, high-stakes environment where traceability, temperature control and documentation accuracy must be guaranteed at every step. And all of this is happening under the watchful eye of the EU Medical Device Regulation (MDR) – a framework that’s redefining how logistics for medical devices must operate.
The European Union (EU) Medical Device Regulation (MDR) governs the production and distribution of medical devices across Europe. The key objective of MDR is to guarantee that medical devices meet safety standards and are fit for use. First introduced in 2017, the regulations came into effect in 2021 and continue to evolve. To comply, medical device manufacturers must undergo a strict conformity process for new and existing products to verify that devices are safe and perform as intended.
Until 2024, countries in the European Economic Area (EEA) accepted certification in line with MDR’s predecessor, the Medical Devices Directive (MDD). While MDR is still evolving, several core requirements are already in effect:
Medical device manufacturers distributing products within the EEA must ensure full supply chain transparency across all European partners.
Clinical data on product safety and performance must be disclosed to authorities.
Traceability throughout the entire product lifecycle is mandatory.
For certain models or types of devices sold in the EU, manufacturers must announce supply interruptions or discontinuations at least six month in advance, especially if patient safety could be affected.
Faced with evolving regulations, growing complexity and rising cost pressure, many medical device companies rethink their logistics strategy.
To remain compliant and competitive, partnering with an experienced 3PL provider who combines regulatory expertise with operational excellence can be crucial.
The ideal logistics partner covers the full scope – from customs clearance and temperature-controlled warehousing at strategic locations to scalable setups and delivery for devices of all sizes – all backed by certified infrastructure and digital transparency. The most important standards include ISO 9001, 13485, 14001 and 50001 – also in place at Rhenus.
Outsourcing logistics to the right partner allows manufacturers to offload compliance risks, reduce chain costs and ensure flawless handling of sensitive goods.
Even though MDR has been in full effect for some time, it’s still worth taking a closer look at how compliance works in practice. Under MDR, there’s zero tolerance for gaps - every detail must be in its place.
When facing regulatory changes like MDR, it's all about implementing structured, transparent processes that secure long-term compliance while addressing the national specifics and legal nuances of each individual European market.
The first step: analyze existing data and systems to identify visibility gaps. Next: integrate MDR-specific logic into your Warehouse Management System (WMS). For example, automatically categorizing products by legislation (MDR or MDD) during picking and packing reduces manual effort and errors.
Maintaining a steady flow of information also helps flag supply issues early, preventing disruptions in healthcare services. This makes visibility and traceability more critical than ever.
A good example comes from a long-term Rhenus customer in the Netherlands.
During the MDR transition, Rhenus worked closely with the customer’s IT team to implement these exact measures:
full visibility across the European supply chain
clear classification of each item according to its regulatory status
and the use of forecasting tools to reduce waste and optimize inventory levels.
For more insight into how this collaboration evolved and supported compliance under real-world conditions, check out our detailed Case Study!
Long-term partnerships mean continuously refining logistics setups to stay compliant and efficient. Here’s how medical device manufacturers can get even more out of their supply chains.
As a regulatory necessity, manufacturers must always know where their products are and how they are handled. Insights into inventory, reservation flows and compliance-relevant data can be gained via a connected customer portal. The base for this is a strong Warehouse Management system, offering real-time data visibility over the locations, operations and costs of medical device management. This provides a significant advantage during audits or internal reviews.
Compliance doesn’t stop with systems. Expertise and service also mean open discussions as well as conducting extra checks, such as verifying whether customers hold the right licenses for specific medical applications and ensuring high-value items are stored in secure, access-controlled zones.
Depending on individual quality requirements, regular cycle counts, clear service-level agreements and proactive communication are essential pieces to build trust and consistency across the supply chain. Monthly reports provide full visibility into adherence to agreements, deliveries, as well as inbound and outbound performance. On top of that reassurance, this helps medical devices manufacturers stay in control and audit-ready.
When inbound and outbound processes connect seamlessly with value-added services (VAS), warehousing gains the extra control function, overseeing safe, efficient processes and, at the same time, enhancing compliance in terms of traceability and documentation. VAS can not only translate MDR requirements into practice but also make the warehouse an extension of the production facilities.
Kitting, repackaging and bundling: Upon receiving an order from an end customer, multiple items are combined into a single, complete shipment – such as the main device and accessories. This way, the order arrives ready for use and appears to come directly from the supplier.
Labeling: Clear labeling of hazardous goods and MDR classifications ensures shipments meet safety standards and are fully audit-ready.
Serial number scanning and batch control: These steps at outbound ensure traceability for each unit – critical for recalls, documentation and MDR audits.
Even when devices are returned or show signs of malfunction, MDR compliance must remain intact. Every return, inspection and repair must follow clear, traceable procedures.
That’s why it’s essential to have a specialized team and infrastructure in place, not only to handle repair or returns efficiently, but to ensure every step follows a structured Return Merchandise Authorization (RMA) workflow.
At the Rhenus location in Tilburg, for example, returned medical equipment is inspected, repaired, or updated under strict MDR protocols – ensuring every step is documented and compliant.
MDR-compliant logistics doesn't have to come at the expense of efficiency. With solutions like automated bin storage, order consolidation and flexible multi-modal shipping, medical device logistics can be both fast and compliant.
The examples and recommendations above show that MDR compliance in warehousing goes far beyond technical systems. In practice, it’s the synergy of people, structured processes and real-time visibility that ensures medical devices meet strict regulatory standards – while still reaching end-users quickly and safely.
For many healthcare companies, keeping up with this complexity internally is no longer feasible. Their core expertise lies in developing and marketing life-saving medical technologies - not in navigating European logistics regulations. That’s where specialized logistics partners like Rhenus step in: combining certified infrastructure, deep regulatory knowledge and hands-on experience in handling all classes of medical products.
With accurate product data, quality-driven processes and a commitment to full transparency, Rhenus ensures that patients and providers alike can rely on consistent, compliant supply chains - even under pressure. This approach efficiently and cost-effectively strengthens compliance and boosts performance.
See how Rhenus can take the complexity out of compliance – and turn logistics into a competitive advantage.
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