Sample Request Global 2026-10-21
PPWR Is Now Applicable: What It Means for Medical Device Packaging？
On 12 August 2026, the EU Packaging and Packaging Waste Regulation (PPWR), Regulation (EU) 2025/40, became applicable across the European Union.
For the medical device industry, this is the beginning of a transition rather than a single compliance deadline. Key PPWR requirements will develop in stages toward 2028, 2030 and 2035, with some application dates depending on future implementing or delegated acts.
Medical Device Packaging Is Within the Scope of PPWR
PPWR explicitly identifies sterile barrier systems — including pouches, trays and materials necessary to preserve the sterility of the product — as packaging. At the same time, the Regulation recognizes the specific requirements associated with certain sensitive applications. Certain contact-sensitive packaging for medical devices and IVDs is therefore exempt from specific recyclability requirements under Article 6. Certain contact-sensitive plastic packaging for medical devices and IVDs is also exempt from the minimum recycled-content requirements under Article 7.The distinction is important: These are specific exemptions — not a general exemption of medical device packaging from PPWR.
For medical device manufacturers, understanding which PPWR requirements apply to each packaging layer will therefore become increasingly important.
For Medical Device Packaging, “Less” Is Not Automatically “Better”. Another important area is packaging minimization. Under Article 10, by 2030, packaging is to be designed so that its weight and volume are reduced to the minimum necessary to ensure its functionality.
For medical device packaging, especially sterile barrier systems, functionality cannot be separated from the requirements of the packaged product.PPWR itself requires packaging minimization to take into account performance criteria including product protection, packaging manufacturing processes, logistics, packaging functionality, hygiene and safety, and applicable legal requirements.
For sterile barrier systems, this means that material reduction needs to be considered alongside factors such as barrier performance, seal integrity, sterilization compatibility, distribution requirements and maintenance of sterility.
The objective is not simply to use less packaging.
It is to eliminate what is unnecessary without compromising what is necessary. Preparing for the Next PPWR Milestones.
For medical device packaging, PPWR brings a new consideration into packaging development: how to improve packaging sustainability while continuing to meet the performance and safety requirements expected of a sterile barrier system.
As the industry moves toward the next PPWR milestones, packaging structure, material selection, product protection, sterile barrier performance and applicable regulatory requirements will need to be considered together.
In addition to recyclability, minimum recycled-content in plastic packaging and Packaging minimization requirements, PPWR Article 5 substance requirements should not be overlooked either. From 12 August 2026, Medical device packaging manufacturers should maintain appropriate material declarations and supporting evidence for substances such as heavy metals, or other substances of concern, where applicable.
At SIGMA, we will continue to follow these developments from the perspective of medical device packaging and sterile barrier systems, helping our customers better understand what evolving packaging requirements may mean for their applications.