(August 12, 2026)
Regulation (EU) 2025/40 on Packaging and Packaging Waste, known as the PPWR, introduces a harmonized European framework for packaging and packaging waste.
The PPWR entered into force on 11 February 2025 and has generally applied since 12 August 2026. Some requirements are introduced through later implementation dates and delegated or implementing legislation.
The Regulation applies alongside the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Compliance with the MDR or IVDR does not automatically demonstrate compliance with the PPWR.
Which packaging is covered?
The PPWR applies broadly to packaging placed on the EU market, regardless of the packaging material, the type of product it contains, or where the packaging was manufactured.
For medical devices and IVDs, this may include:
- immediate or primary product packaging;
- sterile-barrier systems and protective packaging;
- secondary or grouped packaging;
- cartons, trays, pouches, bottles, tubes and protective inserts;
- transport and distribution packaging;
- pallets, pallet wrapping and straps; and
- e-commerce packaging.
Identify and assess each level and component of the packaging system. A packaging component is not automatically outside the scope merely because it is used for a regulated medical device.
What does the PPWR require?
Depending on the packaging type and the applicable implementation date, manufacturers and other economic operators may need to address requirements concerning:
- substances present in packaging;
- minimization of packaging weight and volume;
- recyclability and design for recycling;
- minimum recycled content in plastic packaging;
- compostable or reusable packaging;
- packaging labelling and material identification;
- reuse and packaging-waste prevention targets;
- technical documentation;
- an EU Declaration of Conformity; and
- Extended Producer Responsibility (EPR) registration and reporting.
Not all requirements apply from the same date. A product-specific and packaging-specific assessment is therefore necessary.
Are medical device packages exempt?
Medical device packaging is not generally exempt from the PPWR.
The Regulation provides specific derogations or adjusted timelines for certain contact-sensitive packaging used for medical devices and IVDs. These provisions recognize that changes to packaging material may affect:
- patient and user safety;
- biological compatibility;
- contamination control;
- sterile-barrier integrity;
- shelf life;
- device functionality and performance; or
- compatibility between the device and its packaging.
These provisions are limited to particular PPWR requirements and packaging categories. They should not be interpreted as a complete exemption from the Regulation.
The applicability of a derogation must be assessed and documented for each relevant packaging component.
Standard or stock packaging components
Many medical device manufacturers purchase standard packaging components from specialist packaging suppliers. Examples include stock cartons, pouches, trays, bottles, tubes and transport boxes.
The packaging supplier should provide appropriate supporting information, such as:
- material and composition specifications;
- substance declarations;
- recycled-content information, where applicable;
- test reports and compliance statements;
- information necessary to demonstrate recyclability;
- identification of relevant packaging standards; and
- its PPWR EU Declaration of Conformity, where required.
Purchasing a standard packaging component does not by itself demonstrate that the final packaged medical device complies with all applicable requirements.
The medical device manufacturer should determine whether the information received is adequate and whether the selected packaging is suitable for its intended application. It must also assess the complete packaging configuration, including the combination of primary, secondary, and transport packaging.
Packaging performed by a contract manufacturer
Medical device manufacturers frequently outsource production and packaging activities to a contract manufacturer. The contract manufacturer does not automatically become the responsible PPWR manufacturer merely because it:
- purchases the packaging materials;
- packages the medical device;
- performs packaging validation; or
- arranges transport and distribution.
Responsibility depends on the actual arrangement, including:
- who designs or specifies the packaging;
- who has the packaging or packaged product manufactured;
- under whose name or trademark it is placed on the market;
- whether the packaging is standard or customer-specific;
- who imports the packaging or packaged product into the EU; and
- whether an existing packaging format is subsequently modified.
The legal manufacturer of the medical device may therefore also qualify as a manufacturer under the PPWR where it has the packaging or packaged product manufactured and places it on the market under its own name or trademark.
The roles and responsibilities should be determined for each supply chain. They should be documented in (1) the quality agreement, (2) manufacturing agreement, or (3) a separate packaging responsibility matrix.
The agreement should address at least:
- responsibility for PPWR classification and assessment;
- supplier-data collection;
- packaging testing and validation;
- preparation of technical documentation;
- preparation and signing of the PPWR Declaration of Conformity;
- packaging marking and labelling;
- change notification and change control;
- document-retention periods; and
- cooperation with competent and market-surveillance authorities.
Outsourcing packaging operations does not automatically transfer the legal manufacturer's regulatory responsibility.
Medical device packaging verification and validation
In addition to PPWR compliance, the legal manufacturer remains responsible under the MDR or IVDR for demonstrating that the packaging protects the medical device throughout its claimed shelf life and under the intended storage, handling and transport conditions.
Depending on the device and packaging system, documented evidence may be required for:
- packaging integrity;
- sterile-barrier integrity;
- seal strength and seal-process validation;
- accelerated and real-time aging;
- storage conditions;
- distribution and transport simulation;
- protection against mechanical damage;
- contamination control;
- biological or chemical compatibility;
- packaging-device interaction; and
- legibility and durability of labels.
Relevant verification and validation evidence should be included in, or clearly referenced from, the medical device technical documentation.
Transport packaging should therefore not only be assessed as packaging under the PPWR. It should also be demonstrated that it adequately protects the medical device during foreseeable transportation, storage and handling.
Involvement of the notified body
For devices subject to notified body involvement, packaging documentation may be reviewed as part of the MDR or IVDR conformity assessment or during quality-management-system audits.
The notified body may, for example, review:
- sterile-packaging validation;
- transport and distribution studies;
- shelf-life evidence;
- supplier controls;
- outsourced packaging processes;
- change-control procedures; and
- the relationship between packaging specifications and the device risk-management file.
This review concerns the conformity of the medical device under the MDR or IVDR. It should not automatically be regarded as an independent assessment or certification of PPWR compliance.
The manufacturer remains responsible for establishing and maintaining the applicable PPWR technical documentation and Declaration of Conformity.
EU Declaration of Conformity and technical documentation
Where required, PPWR compliance must be supported by packaging technical documentation and an EU Declaration of Conformity.
The documentation should be sufficiently detailed to identify:
- the packaging and its intended use;
- the packaging components and materials;
- the applicable PPWR requirements;
- applicable derogations and their justification;
- specifications, calculations and test evidence;
- the standards or technical methods used;
- supplier declarations and supporting records;
- the responsible manufacturer; and
- the person authorized to sign the Declaration of Conformity.
The PPWR Declaration of Conformity is legally distinct from the MDR or IVDR Declaration of Conformity for the medical device. Although documentation may be coordinated within the manufacturer’s quality system, the different legal bases and responsible parties must remain clearly identifiable.
Role of the EU Authorized Representative
Appointment as an EU Authorized Representative under the MDR or IVDR does not automatically include representation under the PPWR.
A medical device manufacturer established outside the EU should therefore determine separately:
- whether it qualifies as a manufacturer or another economic operator under the PPWR;
- whether a PPWR Authorized Representative is required or appropriate;
- which PPWR activities are included in the written mandate; and
- which party is responsible for Extended Producer Responsibility obligations in each Member State.
Any PPWR responsibilities assigned to a representative should be expressly included in a written mandate. They should not be assumed to form part of an existing MDR or IVDR Authorized Representative agreement.
Recommended actions for manufacturers
Medical device and IVD manufacturers should:
- Prepare an inventory of all packaging levels and components.
- Identify the packaging supplier, contract manufacturer, importer, and other relevant parties for each packaging configuration.
- Determine the responsible PPWR economic operator.
- Identify the requirements and implementation dates applicable to each packaging component.
- Obtain material specifications, declarations and supporting evidence from suppliers.
- Determine whether any medical-device-specific derogation applies and document the justification.
- Confirm that packaging and transport verification or validation remains adequate.
- Review contracts and quality agreements with packaging suppliers and contract manufacturers.
- Prepare or update the required PPWR technical documentation and EU Declaration of Conformity.
- Establish procedures for supplier changes, packaging changes, document retention and regulatory monitoring.
How QNET can assist
QNET can support medical device and IVD manufacturers with:
- PPWR scope and applicability assessments;
- packaging inventories and responsibility matrices;
- identification of responsible economic operators;
- review of supplier and contract-manufacturer arrangements;
- assessment of medical-device-specific derogations;
- review of packaging technical documentation;
- PPWR Declaration of Conformity templates;
- integration of PPWR controls into the quality-management system; and
- coordination of PPWR requirements with MDR and IVDR packaging documentation.
Early assessment is particularly important where packaging activities have been outsourced or where supporting information must be obtained from multiple packaging suppliers.
This publication provides general regulatory information and does not constitute legal advice. Assess PPWR responsibilities and applicable derogations for the specific packaging, product, and supply-chain configuration.
Official references:
- - Regulation (EU) 2025/40, Packaging and Packaging Waste Regulation
- - European Commission – Packaging Waste Policy
- - European Commission Notice – PPWR guidance for Northern Ireland
- - Guidance document on Packaging and Packaging Waste Regulation (PPWR)
- - FAQ on Packaging and Packaging Waste Regulation (PPWR)