The new EU Packaging Regulation: What medical device manufacturers need to know

What does the regulation require?

The new rules aim to reduce packaging waste, encourage reuse and recycling, and limit the use of hazardous substances. Key requirements include:

• Design obligations: All packaging must be recyclable by 2030 and recyclable at scale by 2035. Certain substances (such as PFAS and BPA) are restricted, and mandatory recycled content will apply to plastics.
• Reuse and refill targets: Specific sectors must meet reuse requirements, supported by refill systems.
• Labelling and information: Harmonised EU-wide labelling and digital data carriers (e.g., QR codes) will provide transparency on recyclability and composition.
• Extended Producer Responsibility (EPR): Producers are responsible for financing and organising collection, sorting, and recycling of packaging waste, with strict reporting obligations.

What about medical devices?

The regulation recognises that safety and sterility cannot be compromised. That is why medical device packaging benefits from important exemptions:

• Recyclability: Immediate packaging in direct contact with medical devices or in vitro diagnostic devices, and outer packaging needed to preserve product quality, are exempt from recyclability obligations.
• Recycled content: Contact-sensitive plastic packaging for medical and in vitro diagnostic devices is exempt from minimum recycled content requirements.

However, manufacturers are still expected to:

• Document and justify the use of exemptions.
• Comply with traceability and conformity obligations under the MDR and IVDR.
• Explore sustainable material innovations where feasible.

Why it matters for medical device manufacturers

While the regulation provides breathing space, it also signals a long-term shift toward sustainable packaging. Exemptions will be reviewed in the future, meaning stricter requirements may apply as technology evolves. Preparing now by investing in eco-design and keeping detailed compliance records will give your organisation a competitive advantage.

Next steps: How to prepare

Medical device manufacturers should:

• Assess which packaging falls under exemptions.
• Review technical documentation and update processes.
• Monitor developments for future regulatory tightening.
• Explore innovation opportunities that align safety with sustainability.

Download our checklist: Packaging compliance for medical devices
Ensure your packaging strategy meets today’s requirements and prepares you for tomorrow’s.