Regulation (EU) 2025/40 (the Packaging and Packaging Waste Regulation, or PPWR) applies to packaging placed on the EU/EEA market from 12 August 2026, with further requirements phasing in through 2028, 2030, 2035 and 2040. It covers both product and transportation packaging, and there is no general exemption for medical devices.
Cook Medical is aware of these obligations and has an active, global compliance program in place addressing packaging identification and labelling, EU Declarations of Conformity, materials and substances compliance, Extended Producer Responsibility (EPR) registration, and importer/distributor obligations.
Our approach
Our initial focus has been on meeting the requirements that apply beginning 12 August 2026, including core packaging identification, labelling, country-specific registrations, Extended Producer Responsibility (EPR) obligations, and supporting compliance documentation.
In parallel, we are building and maintaining the product-level data and documentation needed to support future PPWR requirements as they come into effect. This includes preparing for additional obligations related to packaging labelling, recyclability, packaging minimization, reuse systems, and recycled-content requirements in later phases.
By taking a phased, long-term approach, Cook Medical is positioning itself to meet evolving regulatory requirements while continuing to provide customers with the information and documentation they need to support compliance.