The new EU Packaging and Packaging Waste Regulation (EU PPWR) applies from 12 August 2026. While many provisions have later application dates, from 12 August manufacturers have to a have a Declaration of Conformity and technical documentation in place. For the healthcare sector, the new Regulation applies not only to consumer goods but also to the packaging of medical devices and in vitro diagnostic medical devices (IVDs). While certain exemptions have been introduced to safeguard safety and performance, there is no exclusion for medical device or IVD packaging from the scope of the EU PPWR.
Manufacturers will therefore need to evaluate their packaging compliance alongside their MDR and IVDR obligations.
Main objectives of the EU PPWR
The PPWR’s main objectives are to:
- Reduce packaging waste generation;
- Improve recyclability of packaging;
- Increase the use of recycled materials;
- Harmonise packaging requirements across the EU;
- Promote reuse and refill systems;
- Reduce the environmental impact of packaging throughout its lifecycle.
In this context, manufacturers are required to:
- Verify compliance of packaging;
- Prepare and maintain technical documentation which shows compliance with the PPWR;
- Draw up an EU Declaration of Conformity (DoC) for packaging;
- Assess Extended Producer Responsibility (EPR) obligations;
- Maintain traceability information.
Medical devices and IVDs: exemption from certain EU PPWR requirements
The EU PPWR provides limited exemptions for certain medical device and IVD packaging. These include the requirements on “Design for Recycling”, recyclability performance grades, and minimum recycled content in plastic packaging. In addition, such packaging is exempt from the prohibition on disposal through incineration or landfilling. Further partial exemptions may also apply, although their applicability should be assessed on a case-by-case basis.
For any questions on EU PPWR compliance, contact us here or at mdlaw@obelis.net.
References:
EUR-Lex (2025). Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC. Retrieved 08/07/2026.
European Commission (2026). Guidance document for Regulation (EU) 2025/40 on packaging and packaging waste. Retrieved 08/07/2026.
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