On 12 August 2026, the 18-month transitional period of the PPWR ((EU) 2025/40 – Packaging and Packaging Waste Regulation) will expire. From that date onwards, the first obligations under the Regulation will become legally binding.
What does this mean for medical device manufacturers? In this article, we outline how to prepare in a targeted structured manner and ensure full compliance with all relevant obligations by the deadline.
Implementation in three phases
While our overview article on the PPWR outlines all the key obligations under the Regulation, this article focuses on their practical implementation. For most medical technology manufacturers, implementation can be structured into three phases, as illustrated in the diagram below.
In the first phase leading up to August 2026, the following topics are of particular focus.
Allocation of roles and responsibilities, material restrictions, identification labelling of the manufacturer, conformity assessment by means of technical documentation and extended manufacturer obligations.
Two years later, the first substantive product adaptation will follow, once the harmonised labelling requirements become legally binding.
After a further two years, specific ecodesign requirements for packaging will ultimately apply: Recyclability, minimum recycled content, packaging minimisation and format specifications must then be taken into account.
While a solid level of legal certainty already exists for the first implementation phase, additional delegated and implementing acts for the subsequent phases are still under development. Rather than speculating on future requirements, it is therefore advisable to focus on what is both reasonable and necessary at this stage.
The project plan for achieving compliance
At the outset, it is essential to clearly define your regulatory roles and identify the resulting obligations. It is entirely possible for multiple roles to apply simultaneously. For example, in relation to your sales packaging, you may qualify both as the producer and the manufacturer, whereas for transport packaging, affiliated distribution entities or logistics service providers may assume the respective roles.
Below you will find a tabular overview of the obligations that must be assumed in the first implementation phase in your capacity as producer and manufacturer:
Use the project kick-off to gain a structured overview of the packaging types in use, the corresponding regulatory obligations, and the current compliance status. In parallel, your information systems and processes should be designed in a way that enables reliable compliance tracking of your products.
For example, traceability of material compliance may currently still be manageable through manual solutions. However, it should be taken into account that regulatory requirements are continuously increasing and additional parameters will need to be considered in the future. These include, among others, recycled content, the assessment of recyclability and the ratio of packaging volume to product volume — all of which will need to be clearly assigned to the packaging master data going forward.
Support with Implementation
Have you read this article and are still facing challenges with the implementation of the PPWR?
Our experts at seleon support you both with hands – on implementation and through targeted coaching as well as practical templates designed to enable self-sufficient compliance. All the approaches described are part of our regulatory toolbox – and are tailored precisely to your specific situation.
