Distribution and Retail of Medical Devices in the Shadow of the PPWR Regulation

In the previous issue of the Newsletter, we summarized the key impacts of the new Regulation (EU) 2025/40 on packaging and packaging waste (PPWR). This time, we will focus on the specifics of distribution and retail. Here, the new terms and obligations clash with strict sector-specific regulations under the MDR and IVDR; fortunately, the PPWR provides important exemptions to protect patient safety. These exemptions apply primarily to packaging that is sensitive to contact with the medical device, while group and transport packaging in the supply chain will not be exempt from the new strict environmental limits. Companies must therefore revise their packaging strategies in a timely manner to comply with both sets of regulations without risking penalties.

The key point is that the PPWR uses a different definition of “manufacturer” than the MDR or IVDR. The manufacturer of the packaging need not be the entity that physically manufactures the packaging. It may also be an entity that has the packaging or packaged product designed or manufactured under its own name or trademark, typically in a private-label model. The Regulation also introduces the role of “producer,” which is particularly crucial for extended producer responsibility. A producer is the entity that first makes the packaging or the packaged product available on the market in a given Member State.

In the day-to-day operations of distributors and pharmacies, these roles may be concentrated in a single company. This has implications for labeling, which is an exceptionally critical issue for medical devices. The packaging must indicate the packaging manufacturer, but the PPWR prohibits this new information from being confused with the information required for the medical device itself. In the case of private-label distribution, it is therefore necessary to design the graphics and information on the packaging so that the packaging manufacturer is clearly distinguished from the device manufacturer. Ambiguous differentiation can lead to confusion regarding the responsible entities, which is problematic for devices in terms of traceability, complaints, and vigilance as well.

When does the PPWR give way to the MDR?

A key relief concerns harmonized labels for waste sorting (material composition of packaging), which will be mandatory starting in August 2028. However, the PPWR provides an exception: the requirement to affix a harmonized pictogram to packaging does not apply to the inner and outer packaging of devices if there is no space available due to other labeling requirements. Healthcare legislation therefore takes precedence.

Where the PPWR does not provide exemptions, however, is in logistics and e-commerce. Furthermore, starting in 2030, the empty space in group, transport, and e-commerce packaging must be limited to a maximum of 50%. All filler materials are also counted as “empty space.” However, for medical devices, reducing the packaging size or limiting fillers must not compromise the protection of the device, the sterile barrier, stability during transport, or other safety and quality requirements.

Distributors themselves will play an active role, as they must verify, prior to placing the device on the market, that the manufacturer is registered and that the packaging is properly labeled. Both manufacturers and distributors of medical devices must be thoroughly familiar with the new rules, differences in regulations, and exceptions.

Author: Markéta Hrubá