The Packaging and Packaging Waste Regulation (PPWR) is moving from preparation to implementation. While many medical device manufacturers have focused primarily on compliance with MDR and IVDR, 12 August 2026 marks an important milestone for packaging compliance that should not be overlooked. From this date onwards, packaging placed on the market will require a Declaration of Conformity (DoC).
The recently published European Commission guidance on the PPWR does not introduce new legal requirements. However, it does provide valuable clarification on how the Regulation applies to medical devices and IVDs, helping manufacturers better understand their responsibilities.
Who is responsible?
One important clarification in the guidance is that the legal manufacturer, or importer where applicable, remains responsible for PPWR compliance of the packaging. This responsibility does not automatically transfer to the packaging supplier or contract manufacturer, even if they design or produce the packaging.
Suppliers can, however, play a key role by providing the technical documentation manufacturers need to substantiate their Declaration of Conformity.
Who is responsible?
The guidance also helps distinguish between packaging and components that are part of the medical device itself.
For example:
- - A carton or shipping box, including its labels, is considered packaging and falls within the scope of the PPWR.
- - An IV bag or syringe is not packaging. These items are considered an integral part of the medical device and therefore fall outside the scope of the PPWR.
- - Sterile barrier systems and other packaging that maintains the sterile condition of a device are currently derogated because this packaging affects safety, sterility or performance.
Understanding these distinctions is essential when determining which materials require a PPWR Declaration of Conformity.
The heavy metals requirement
The PPWR requirement limiting the combined concentration of lead, cadmium, mercury and hexavalent chromium to 100 ppm is not new. This requirement has existed for many years under the Packaging and Packaging Waste Directive (94/62/EC).
What has changed is that, under the PPWR, compliance becomes much more explicit. Manufacturers will need to demonstrate conformity through documented technical evidence and a formal Declaration of Conformity.
Immediate actions
Manufacturers should already be:
- Identifying which packaging components fall within the scope of the PPWR.
- Collecting compliance evidence from packaging suppliers.
- Confirming compliance with the 100 ppm heavy metals restriction.
- Preparing the technical documentation needed to support the PPWR Declaration of Conformity.
Taking these steps now can help prevent delays as the August 2026 deadline approaches.
The future of the PPWR
While 12 August 2026 marks the first major compliance milestone, it is far from the last.
The PPWR introduces a phased implementation roadmap with additional requirements extending to 2040, including obligations related to recyclability, recycled content, packaging minimisation and harmonised labelling. Companies should, therefore, view August 2026 not as the finish line, but as the beginning of a broader packaging compliance journey.
Need support with PPWR compliance?
At Qserve, we support medical device and IVD manufacturers in understanding the practical impact of the PPWR and preparing the documentation required for compliance. Whether you need help determining if your packaging falls within scope or assessing whether your technical evidence is sufficient, our regulatory specialists are ready to support you.