Healthcare packaging is not automatically exempt from PPWR
From 12 August 2026, medical device, IVD and pharmaceutical packaging may need to meet PPWR requirements. Specific exemptions exist, but core obligations can still include conformity assessment, technical documentation, an EU Declaration of Conformity and extended producer responsibility.
Download the practical guide to understand what applies to your packaging and how to prepare.
PPWR for Life Sciences: A Practical Guide to Compliance
This guide breaks down the EU Packaging and Packaging Waste Regulation (PPWR) for medical device, IVD, and pharmaceutical packaging, and how osapiens HUB helps you manage compliance across your supply chain.
The guide covers:
- What PPWR requires for medical device, IVD, and pharmaceutical packaging
- Primary, secondary, and tertiary packaging, and why the distinction matters
- Which requirements apply in full and which carry conditional exemptions
- Key deadlines from August 2026 through 2040
- A step-by-step path to compliance, from mapping packaging roles to EPR registration
Does PPWR apply to your organization?
PPWR covers packaging placed on the EU market, including packaging supplied by companies based outside the EU. Companies selling medical devices, IVDs or pharmaceuticals in Europe should assess their packaging and supply-chain responsibilities.
EU manufacturers
Determine which requirements apply to each product and packaging layer.
Non-EU exporters
Provide EU importers with the required packaging documentation and conformity evidence.
Importers and distributors
Verify that the relevant documentation, labelling and registrations are in place.
Specific exemptions exist, but core obligations still apply
Requirements that can still apply
Conformity assessment
Technical documentation
EU Declaration of Conformity
Supplier information obligations
Importer obligations
Producer registration
Extended producer responsibility
Packaging minimization
Specific exemptions may apply to
Design for recycling
Minimum recycled content
Harmonized sorting labels
Particular reuse targets
Specific exemptions exist, but core obligations still apply
From 12 August 2026, companies need to understand their PPWR role, determine which requirements apply to each packaging layer and obtain the necessary information from suppliers.
For many healthcare and life sciences companies, the immediate challenge is creating reliable technical documentation and an EU Declaration of Conformity from packaging data that is currently spread across suppliers, systems, emails and spreadsheets.
From supplier data to an audit-ready Declaration of Conformity
Achieve PPWR Compliance with ease
The regulation states that from August 12, 2026 onwards, all packaging and packaged goods that are placed on the EU market must comply with the PPWR. This affects all products and all industries!
The PPWR applies to:
- suppliers of packaging or packaging materials
- manufacturers of packaging or packaged products
- distributors, importers, and fulfillment service providers
- brand owners that place packaged goods on the EU market
- non-EU suppliers who supply products or packaging for the EU market
The PPWR significantly impacts:
- FMCG/ consumer packaged goos (food, beverage, care)
- retail/ e-commerce/ online marketplaces
- packaging manufacturing industry
- logistics, fulfillment, and transport packaging industry
- textile, apparel, and footwear (packaging side)
- hospitality, food service, and takeaway (HORECA)
The main PPWR requirements in this area are:
- chemical safety (limits for REACH, PFAS, etc. in packaging)
- recycling capability (2030: at least 70% recyclable; 2038: at least 80% recyclable)
- use of post-consumer recycled material (2030: different percentages depending on packaging type/ material)
- minimization of packaging (2030: maximum empty space ratio of 50%)
- reusability (re-use or re-fill for food and drink; 2027: details defined in a delegated act)
- bans and restrictions on certain packaging types (2030: specific single-use packaging banned)
The PPWR requires transparency by labeling etc. (uniform labelling including information about used materials etc.). Manufacturers must carry out the conformity assessment for their packaging (incl. supplier information) and draw up the technical documentation and the EU declaration of conformity. Within the framework of the Extended Producer Responsibility (EPR) all producers ( = manufacturers, importers or distributors who place packaging or packaged products on the market for the first time) must enroll at the register in the Member States where they place products, report and update relevant data and pay EPR fees for collection, sorting and recycling of used packaging waste.