Assess packaging as a program

The source perspective examines the EU Packaging and Packaging Waste Regulation and its implications for medical device manufacturers. It highlights distinctions between packaging needed for safety or sterility and secondary or tertiary materials that may face different obligations.

Connect the work across functions

Begin with a documented gap assessment covering materials, labeling, supplier information, technical documentation, and registration responsibilities. Evaluate material changes against product protection and existing device requirements. Engage procurement, quality, regulatory, operations, and suppliers early so a sustainability change does not create a new product risk.

Maintain a dated requirements baseline

The original article was published in August 2025 and discusses a multiyear implementation horizon. Use it as a planning perspective, then verify current legal text, exemptions, and applicable dates before making compliance decisions. Assign ownership for maintaining readiness after the initial program closes.

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