The Packaging and Packaging Waste Regulation (PPWR) applies across all industries. Consequently, manufacturers of medical devices and pharmaceuticals must generally also comply with the requirements of the regulation. However, exemptions are provided for certain applications in the pharmaceutical and medical technology sectors. The reason: In these sectors, the packaging requirements associated with the PPWR can pose safety risks to patients or users. In such cases, the benefits of specialized packaging solutions outweigh the potential advantages of the regulation.
What Exemptions Does the PPWR Provide for Pharmaceutical and Medical Device Manufacturers?
In principle, the PPWR applies to all economic operators and all industries. However, certain sectors benefit from extensive exemptions. In order to protect human and animal health and to ensure product safety and quality, pharmaceutical and medical device manufacturers are exempt from a number of obligations.
Exemptions from the Recyclability Requirements under Article 6 PPWR
The requirements for design for recycling (DfR), which will apply progressively from 2030 onwards, as well as the subsequent obligation relating to large-scale recycling, do not apply to:
- Primary packaging (immediate packaging) that comes into direct contact with medicinal products for human use (under Directive 2001/83/EC) or veterinary medicinal products (under Regulation (EU) 2019/6).
- Outer packaging of medicinal products for human or veterinary use within the meaning of the same legal acts, where such packaging is strictly necessary to meet specific quality and preservation requirements of the medicinal product.
- Contact-sensitive plastic packaging for medical devices covered by Regulation (EU) 2017/745.
- Contact-sensitive plastic packaging for in vitro diagnostic medical devices covered by Regulation (EU) 2017/746.
- Packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC.
Exemptions from the Minimum Recycled Content Requirements for Plastic Packaging under Article 7 PPWR
The obligations relating to the incorporation of post-consumer recycled plastic content, which will be introduced progressively from 2030 onwards, do not apply according to the PPWR in some cases MedTech and Pharma companies, in example for:
- Primary packaging for medicinal products for human use (Directive 2001/83/EC) and veterinary medicinal products (Regulation (EU) 2019/6).
- Outer packaging of medicinal products for human or veterinary use where such packaging is necessary to ensure product quality.
- Contact-sensitive plastic packaging for medical devices covered by Regulation (EU) 2017/745, including products intended exclusively for research purposes or testing.
- Contact-sensitive plastic packaging for in vitro diagnostic medical devices covered by Regulation (EU) 2017/746.
- Packaging for manufacturing components, including packaging for supplies, components, and primary packaging components required for the manufacture of medicinal products, where necessary to comply with quality standards.
- Packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC.
Conformity Assessments of Packaging
Since 12 August, there has been an obligation to issue a declaration of conformity for packaging with regard to certain substance requirements. Particular attention is given to limit values for heavy metals and PFAS (per- and polyfluoroalkyl substances).
Packaging that comes into direct contact with food is of particular importance, as the PFAS requirements must be explicitly taken into account for such packaging. For food-contact packaging, the PPWR establishes specific limits and restrictions for PFAS compliance, which must be demonstrated and documented.
The data required for these assessments is generally provided by the packaging supplier, who supplies the relevant material and substance information. However, the responsibility for the conformity assessment remains with the producer.
The resulting documentation must be available in the official language of the country in which the packaging is placed on the market. Companies therefore require processes that enable the preparation of country-specific documentation and translations.
Exemptions from Conformity Assessments and Technical Documentation (Article 15)
The obligation to carry out conformity assessment procedures and to prepare and retain technical documentation (Article 15(2) and (3)) does not apply to:
- Custom-made transport packaging for configurable medical devices and medical systems specifically intended for use in industrial and healthcare environments.
Packaging Labeling Requirements under the PPWR
“PPWR makes packaging more data-intensive. Companies that do not have control over their packaging and product data today may face difficulties tomorrow in efficiently meeting regulatory transparency requirements.”
Stefan Hoffmann, CEO, tracekey solutions GmbH
Requirements for Data Management and Master Data
One of the key areas of action in the coming years is the establishment of robust data structures for packaging information. Companies should begin systematically collecting the required data today, as this information will be needed in the future for conformity assessments, labeling obligations, and consumer information requirements.
Relevant information includes, in particular, a unique packaging identifier, for example through article, batch, or serial numbers; classification according to the respective packaging type (primary, secondary, or transport packaging); the materials used; and their respective weight shares. The PPWR provides for a harmonized material classification system consisting of 22 material categories.
For many companies, this will represent a significant expansion of existing master data requirements. A purely Excel-based data management approach is unlikely to be sufficient in the long term to ensure the required level of data quality, traceability, and data maintenance.
- Labeling: Packaging must in future be labeled in a harmonized manner, for example with regard to material composition, recyclability, or reusability. In some cases, digital information (e.g. via a QR code) is mandatory.
Exemptions from Labeling Requirements (Article 12)
The harmonized requirements for the physical labeling of packaging (e.g. material composition) do not apply to primary and outer packaging of medicinal products for human use, veterinary medicinal products, medical devices, and in vitro diagnostic medical devices under the following conditions:
- Where there is insufficient space on the packaging due to specific labeling requirements under other EU legislation applicable to these sectors.
- Where additional labeling could compromise the safe use of the medicinal product.
The new labeling requirements will be introduced gradually. Initial labeling obligations apply to certain packaging types as early as 2026. However, full implementation of the harmonized labeling requirements will only become mandatory from 2028 onwards.
From that point, in addition to existing material and packaging information, additional consumer information must be provided. This includes, in particular, harmonized material identification and standardized disposal instructions. The corresponding symbols and icons will be defined uniformly across the EU.
The information may be provided either directly on the packaging or digitally through a QR code that allows end users to access the required information. Companies should therefore begin assessing at an early stage how digital product and packaging information can be managed and made available in the future.
Extended Producer Responsibilities and Reporting Obligations within National Systems
In addition, manufacturers are required to register in the national registers of the respective Member States. In Germany, for example, registration is carried out through the LUCID Packaging Register. Participation in collection and recovery systems is already well established for many companies and does not, in principle, represent a new PPWR requirement.
- Information and reporting obligations: Manufacturers must report packaging volumes to the competent authorities and inform consumers about proper disposal and reuse.
- Extended Producer Responsibility (EPR): Manufacturers must register in the relevant Member States, participate in packaging take-back and waste management schemes, and bear the costs of collection and recycling.
What Measures Should MedTech and Pharmaceutical Manufacturers Implement Now to Achieve PPWR Compliance?
Even, and especially, because certain obligations are already applicable, companies should:
- Define which role(s) their organization assumes under the PPWR and understand the obligations associated with those roles.
- Coordinate with suppliers and obtain the necessary data where required.
- Clarify which exemptions apply to their business, whether as a micro-enterprise or as a manufacturer of medicinal products or medical devices benefiting from specific exemptions.
- Review the packaging currently in use and assess whether the materials comply with PPWR requirements.
- Prepare declarations of conformity for heavy metals and PFAS where necessary.
- Complete registrations in the relevant national producer registration systems.
[Disclaimer]
The information provided here represents only one possible interpretation of the applicable regulations. Regulatory requirements are continuously evolving, which means that the information in this article may be incomplete or no longer fully up to date. This article does not constitute legal advice. Please refer to the official regulatory documents before making any business decisions. (Information status: September 2026)