Another Challenge for Manufacturers: The New EU Packaging Regulation

The EU is now introducing major changes to product packaging rules. The brand-new Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) introduces stricter requirements for eco-design, recyclability, and packaging minimization. The changes will also affect the medical device sector, which is primarily governed by the MDR and IVDR. Although the PPWR generally applies to all packaging placed on the market, it introduces exceptions for medical devices to protect patient safety and health. However, this does not mean that medical devices are completely exempt from the scope of the PPWR or that their manufacturers are not subject to the obligations under this regulation.

Manufacturers and distributors of medical devices cannot avoid a number of general obligations. Packaging manufacturers—which include entities that have packaging manufactured under their own brand—must ensure conformity assessment, prepare technical documentation, and issue an EU declaration of conformity. Distributors then verify, prior to placing the product on the market, that the manufacturer has fulfilled these obligations and properly labeled the packaging.

Manufacturers must pay particular attention to chemical substances. Among other things, the PPWR introduces a strict limit on PFAS—so-called “forever chemicals”—in packaging intended to come into contact with food. This limit will take effect as early as August 2026.

Another new feature is Extended Producer Responsibility (EPR). A producer is an entity that places either packaging or a packaged product on the market for the first time in a specific Member State and is responsible for financing the waste management system. Producers will be required to register in national registries and regularly report the quantity of packaging placed on the market. At the same time, there is a general pressure on everyone to minimize packaging and reduce empty space to the absolute minimum.

Partial Exemptions for Medical Devices

However, the PPWR introduces minor exemptions for medical devices in certain areas, as maintaining sterility—and thus the safety of the device for users—remains an absolute priority. Although the regulation requires full recyclability of packaging starting in 2030, this requirement does not currently apply to packaging intended to come into contact with products falling under the scope of the MDR and IVDR, i.e., primary packaging for medical devices.

Similarly, the mandatory minimum content of recycled material in primary plastic packaging for these sensitive products will not apply, due to the need to protect against contamination. Another exception concerns packaging labeling—new harmonized labels and pictograms for waste sorting will not be required if there is no space left on the packaging due to MDR or IVDR labeling, or if such labeling could compromise the safe use of the device.

Custom-made transport packaging for configurable medical devices and systems intended for healthcare facilities is also exempt from conformity assessment requirements.

Author: Markéta Hrubá