Medical Device Makers, Gear Up for the Next EU Regulation

Okay, so you’ve completed (or at least begun) all the work to make your medical device compliant with EU MDR or IVDR. But the EU isn’t done changing regulations on you.

Have you heard about the latest EU regulation change that will affect your medical device? It’s called the EU Packaging and Packaging Waste Regulation (EU PPWR). And there is no blanket exemption for medical devices unless it directly impacts sterility or safety. So if you are selling devices in the EU, it applies to you.

Don’t worry, I’ve done the research. Here’s a summary of what you need to know.

Overview of the EU PPWR

The EU PPWR (Regulation EU 2025/40), adopted in December 2024 and effective February 11, 2025, replaces Directive 94/62/EC. It aims to harmonize packaging rules across the EU.

Key objectives:

• Reduce packaging waste by 5% (2030), 10% (2035), and 15% (2040) vs. 2018 levels.
• Ensure all packaging is recyclable by 2030.
• Increase reuse and refill systems.
• Mandate recycled content in plastic packaging.
• Ban hazardous substances like PFAS in packaging.
• Implement Extended Producer Responsibility (EPR) rules to hold manufacturers, importers, and brand owners responsible for the waste generated from their products.

There Are Some Exemptions for Medical Packaging

Due to the critical role of packaging in maintaining sterility, safety, and regulatory compliance, PPWR provides partial exemptions for medical devices:

• Design for recyclability and reuse requirements may not apply to primary packaging if they compromise product safety or sterility.
• Minimum recycled content requirements are waived for certain medical packaging, allowing for the use of virgin materials.
• Labeling exemptions may apply to packaging that can’t be altered without affecting compliance with the EU MDR.

However, secondary and tertiary packaging (e.g., shipping cartons) are not exempt and must meet recyclability and labeling standards.

But Compliance Requirements Still Apply

Despite exemptions, medical device manufacturers must still comply with several PPWR mandates:

• Conformity assessment and technical documentation for all packaging.
• Registration in packaging registers.
• EPR fees, which are lower for sustainable packaging.
• Labeling with standardized recycling symbols and material codes.

Implementation Timeline

Strategic Considerations for MedTech Companies

Medical device manufacturers should:

• Assess the regulation changes against the current state.
• Conduct a gap analysis of current packaging vs. PPWR requirements.
• Create and implement an integrated plan to close the gaps and achieve compliance.
• Explore material innovations that maintain sterility while improving recyclability.
• Engage with stakeholders (regulators, suppliers, healthcare providers).
• Implement Lifecycle Assessment (LCA) tools to evaluate environmental impact.
• Create and implement a sustaining plan to maintain compliance.

Don’t Delay

The PPWR introduces significant regulatory changes. And the first provisions, such as registration and a conformity assessment, become applicable in less than a year. Besides the explicit changes, expect indirect impacts—such as supply chain shifts, market expectations, and EPR costs—and incorporate these in your proactive planning.

If we’ve learned anything from EU MDR, you need to get to work on it right away. Recognize this for what it is, a product remediation program, and set up a program structure that aids information gathering, decision making, and prioritization. You have no time to waste in setting up your program, gaining executive approval, and starting your gap assessment.

August 26, 2025