The EU Packaging and Packaging Waste Regulation (PPWR) will become applicable on 12 August 2026 and will replace the current Packaging and Packaging Waste Directive, which has been in force since 1994, along with its national implementing measures.
While the PPWR introduces new requirements and harmonises existing provisions, the fundamental responsibilities—including the financing of collection, take‑back, and recycling systems—have been in place for many years.
We would like to break down two relevant areas of obligations that are relevant:
1) Obligation as a manufacturer of packaging (product conformity)
The new PPWR affects all manufacturers who produce packaging or place products on the market in packaging under their own name or trademark. These manufacturers are required to meet the sustainability requirements for packaging until the application date 12 August 2026. This includes in particular:
- Assessment of the manufacturer role (who qualifies as a “manufacturer” of the packaging within the meaning of the PPWR);
- Conducting a conformity assessment procedure for packaging;
- Ensuring compliance with the substantive requirements of the PPWR (e.g. recyclability, minimisation, use of recycled content, substance requirements);
- Preparation of the technical documentation as evidence of conformity;
- Issuance of an EU Declaration of Conformity;
- Compliance with labelling and information obligations;
- Ensuring that only compliant packaging is placed on the market;
- Retention of the technical documentation and making it available to market surveillance authorities.
2) Obligation as a producer within the meaning of the Extended Producer Responsibility (EPR)
The EPR applies to the Producer. The Producer can be different legal entities. It means manufacturer, importer or distributor. The condition under which a client of MDSS (a non-EU manufacturer) is considered as a producer of packaging is set out in Article 15(1) point d) of the PPWR. Where a non-EU manufacturer makes packaged products available on the market in an EU Member State directly to end users (patients, consumers, or healthcare facilities) for the first time, the obligations of EPR apply.
Typical EPR obligations include in particular:
- Assessment of the producer role (who qualifies as a Producer for EPR purposes);
- Registration with the competent national authority or in the packaging register (e.g. LUCID in Germany);
- Appointment of an authorised representative*, where required at national level;
- Conclusion of a system participation agreement with an approved take‑back and waste management scheme;
- Financing of the collection, sorting, recovery, and disposal of the packaging quantities placed on the market;
- Regular reporting of quantities to authorities and system operators;
- Submission of declarations of completeness or annual reports, where required under national law;
- Evidence and documentation obligations vis‑à‑vis authorities and systems;
- Ensuring participation in the respective national take‑back and recycling systems.
*It is important to note that this EPR authorised representative is not the same as the authorised representative (“EC REP / EU REP”) known under the MDR/IVDR or other EU product legislation, and it also differs from the authorised representative pursuant to Article 17 of the PPWR.
These obligations are purely EPR‑related and concern the placing on the market of packaging and the financing of its end‑of‑life management.
Non-EU manufacturers who sell packaging via distribution entities (importer) are most likely exempt from this obligation. This is because, under the definition, the importer is the entity that places the packaging on the EU market and therefore qualifies as a Producer with the EPR.
▶ `Importer` means any natural or legal person established within the Union that places packaging from a third country on the market; (PPWR Art. 3 (17))
▶ `placing on the market` means the first making available of packaging, whether empty or with a product, on the Union market (PPWR Art. 3 (10));
Again, if the non-EU manufacturer sells directly to patients, consumers, healthcare facilities, the EPR obligations are most likely applicable to the non-EU manufacturer.
3) Additional EPR schemes (in particular WEEE and batteries – also relevant for medical devices)
In addition to packaging, companies often need to take into account further EPR obligations, in particular those arising from Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) and EU Battery Regulation (EU) 2023/1542.
This is particularly relevant for medical devices, as many of these products contain electrical or electronic components and/or batteries (e.g. diagnostic equipment, infusion pumps, portable medical devices, or devices with integrated rechargeable batteries).
In such cases, the following additional obligations apply:
EPR WEEE obligations (electrical and electronic equipment) / battery obligations (batteries, accumulators):
- Registration as a manufacturer with the competent national WEEE/battery authority;
- Classification and allocation of the product to the relevant equipment category or battery category;
- Financing of the collection, take‑back, and disposal of waste equipment/batteries;
- Conclusion of contracts with take‑back schemes or collective systems;
- Reporting of quantities of equipment/batteries placed on the market;
- Organisation and/or financing of take‑back from the market;
- Compliance with information obligations towards end users (e.g. marking with the “crossed‑out wheeled bin” symbol);
- Provision of data to take‑back schemes and authorities.
From a practical compliance perspective, the EPR obligations under the PPWR, the WEEE Directive and the Battery Regulation follow a largely comparable logic. In all three frameworks, for medical device manufacturers acting as a Producer under the respective packaging, WEEE and battery EPR schemes, these obligations should be assessed together, as multiple EPR regimes may apply simultaneously to the same product.
4) Note on completeness and risks
Failure to comply with the above‑mentioned obligations for packaging, WEEE, and batteries may entail significant consequences depending on the EU Member State, including in particular:
- High fines and administrative penalties;
- Sales bans and restrictions on market access;
- Retroactive claims for EPR fees;
- Retroactive disgorgement of profits;
- And, in some jurisdictions, personal liability of managing directors.
The primary concern for non-EU manufacturers engaged in direct sales to end users, consumers, or healthcare facilities is the potential risk for sales bans and restrictions on market access.
Contact us:
Due to national implementation of EU legislation, each Member State operates its own EPR system. Currently, there are more than 500 take‑back systems across the EU. As MDSS is committed to guiding its clients through these complex regulatory pathways we cooperate with experienced partners who can fully support companies in fulfilling their EPR and related compliance obligations. Please feel free to contact us if you have any questions.
