The European Union has officially introduced the Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR), replacing the Packaging and Packaging Waste Directive (94/62/EC), which had been in place for nearly three decades.
The PPWR will apply from August 12, 2026, introducing comprehensive requirements for the sustainability, design, labeling, use, and end-of-life management of packaging throughout its entire lifecycle.
For medical device manufacturers exporting products to the EU, CE marking is no longer the only compliance consideration. Product packaging must also be assessed against the applicable PPWR requirements.
Below is an overview of the key requirements and compliance considerations.
Regulation: EU Packaging and Packaging Waste Regulation (EU) 2025/40
01 What Is the PPWR?
PPWR, or the Packaging and Packaging Waste Regulation (EU) 2025/40, is the EU’s new harmonized and legally binding regulatory framework governing packaging and packaging waste.
Unlike the previous directive, the PPWR establishes a more consistent set of requirements across EU Member States and addresses packaging throughout its entire lifecycle, from design and production to use, collection, recycling, and disposal.
02 What Are the Key Objectives of the PPWR?
The PPWR introduces sustainability and labeling requirements covering the entire packaging lifecycle, including packaging production, use, and waste management.
The regulation aims to:
- Reduce unnecessary packaging and promote packaging reuse, refill systems, and recycling;
- Harmonize packaging-related requirements across EU Member States to reduce trade barriers and prevent distortions of competition;
- Support the transition to a circular economy and contribute to the EU’s objective of achieving climate neutrality by 2050.
03 What Does the PPWR Apply To?
The PPWR applies broadly to packaging and packaging waste placed on the EU market.
Its requirements may affect various economic operators, including packaging manufacturers, importers, distributors, and other businesses involved in placing packaged products on the EU market.
The regulation covers a wide range of packaging formats and materials, including:
- Sales packaging;
- Grouping packaging;
- Transport packaging;
- Plastic packaging;
- Paper and cardboard packaging;
- Glass packaging;
- Metal packaging; and
- Composite packaging.
For medical device manufacturers, this means that packaging used for products supplied to the EU market may need to be reviewed for PPWR compliance in addition to the applicable medical device regulatory requirements.
04 What Packaging Requirements Does the PPWR Introduce?
The PPWR establishes a range of requirements designed to improve the environmental performance of packaging throughout its lifecycle.
Key areas include:
- Packaging minimization — reducing unnecessary packaging and avoiding excessive use of materials;
- Improved recyclability — ensuring packaging is designed to be recyclable;
- Use of recycled materials — increasing the incorporation of recycled content where applicable;
- Restrictions on substances of concern — limiting certain hazardous or environmentally harmful substances in packaging;
- Reuse and refill — promoting reusable packaging systems where applicable;
- Labeling and information requirements — improving the availability and consistency of packaging-related information; and
- Extended Producer Responsibility (EPR) — requiring responsible parties to fulfill applicable registration, reporting, and financial obligations related to packaging waste management.
Medical device manufacturers should therefore assess not only the device itself, but also the materials, design, labeling, and lifecycle management of its packaging.
05 What Documents Are Required for PPWR Compliance?
Depending on the applicable requirements and packaging characteristics, companies may need to prepare supporting compliance documentation, including the following:
1. Technical Documentation
Technical documentation may include:
Basic Packaging Information
Information on the packaging type, structural characteristics, materials, intended use, and other basic specifications.
Design and Manufacturing Information
Packaging design specifications, technical drawings, component and material information, as well as details of the packaging structure and manufacturing process.
Regulatory and Technical Basis
Identification of applicable harmonized standards, common specifications, technical requirements, and other relevant regulatory references used to demonstrate compliance.
Conformity Assessment Documentation
Documentation describing how the packaging has been assessed against applicable PPWR requirements, such as requirements concerning recyclability, packaging minimization, and reusability.
Testing and Verification Records
Relevant test reports, verification records, and other supporting evidence demonstrating that the packaging meets applicable regulatory requirements.
2. Declaration of Conformity (DoC)
Where required, the company should prepare a Declaration of Conformity (DoC) to formally demonstrate that the applicable packaging requirements have been met.
06 What Are the Potential Consequences of PPWR Non-Compliance?
Failure to comply with applicable PPWR requirements may expose companies to a range of regulatory and commercial risks, including:
- Requirements to modify or redesign packaging;
- Restrictions on placing products on the EU market;
- Regulatory inspections and enforcement actions;
- Additional compliance and remediation costs; and
- Delays or disruptions to market access.
In addition, failure to fulfill applicable EPR registration, reporting, and fee obligations may affect a company’s ability to lawfully place packaged products on the market in certain EU Member States.
For companies exporting medical devices to the EU, packaging compliance should therefore be incorporated into the overall market access and compliance strategy rather than treated as a separate environmental issue.
07 PPWR Compliance Services Provided by GRZAN
GRZAN Group provides professional PPWR compliance support for companies placing packaged products on the EU market, including medical device manufacturers.
Our services include:
- PPWR Authorized Representative Services
- Technical Documentation Preparation and Compliance Support, including initial preparation and subsequent changes
- Declaration of Conformity (DoC) Preparation and Compliance Support, including initial preparation and subsequent changes
- Support for Establishing and Implementing Applicable Manufacturer Obligations and Compliance Processes
- Other PPWR Regulatory Consulting Services
Conclusion
The implementation of the EU Packaging and Packaging Waste Regulation (PPWR) introduces new compliance obligations for companies placing packaged products on the EU market.
For medical device manufacturers, CE marking is only one part of the overall EU market access framework. Product packaging, as an integral part of the medical device supply chain, may also need to meet applicable sustainability, recyclability, labeling, material, and EPR requirements under the PPWR.
Companies planning to enter or continue operating in the EU market should assess PPWR and EPR requirements at an early stage, review their packaging materials and documentation, and establish an appropriate compliance strategy to minimize regulatory risks and avoid unnecessary market-access costs.