With Regulation (EU) 2025/40 (PPWR), the EU introduces new rules for packaging. This also affects medical devices and in vitro diagnostic devices – in addition to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), which govern the product itself.
Most requirements will apply from 12 August 2026.
What is it about?
In future, packaging must:
- be more environmentally sustainable (e.g. recyclable) – Articles 6–9 PPWR
- be reduced – Article 10 PPWR
- comply with certain substance restrictions – Article 5 PPWR
What does EPR mean?
EPR = Extended Producer Responsibility
Companies are required to bear the costs for the waste management and recycling of their packaging.
Legal basis: in particular Articles 44 and 45 PPWR
Who is concerned?
Producer (Article 3(13a) and (13b) PPWR): means any natural or legal person that manufactures packaging or a packaged product, or has it designed or manufactured under its own name or trademark.
The producer must carry out conformity assessment procedures for various obligations.
Manufacturer (Article 3(15) PPWR): means any person or company that first makes packaging or packaged products available on the market within a Member State. This includes:
- first making available transport, service or primary production packaging in the country of origin
- supplying products in other packaging directly to end users
- direct supply of packaging to end users
- unpacking products without being the end user
Importer (Article 3(17) PPWR): means any natural or legal person established in the Union that places packaging from a third country on the market. The importer primarily has due diligence obligations.
Distributor (Article 3(18) PPWR): means any natural or legal person in the supply chain, other than the producer or importer, who makes packaging or packaged products available to resellers or end users.
Authorised representative (Article 3(19) PPWR): means any natural or legal person established in the Union who has received a written mandate from the producer to act on their behalf in relation to specified tasks.
What obligations must be fulfilled?
- Producers (Article 15 PPWR):
- ensure packaging compliance
- prepare technical documentation and an EU declaration of conformity (Article 39 PPWR)
- fulfil registration and EPR obligations
- Importers (Article 18 PPWR):
- verify compliance prior to placing on the market
- ensure documentation is available
- fulfil EPR and registration obligations
- Distributors (Article 19 PPWR):
- only make compliant products available on the market
- take corrective actions where necessary (e.g. recalls)
- Authorised representatives (Article 17 PPWR):
- support the producer
- act as a contact point for authorities
- ensure availability of documentation
Specific considerations for medical devices and IVDs
Two regulatory frameworks apply in parallel:
- Product → MDR / IVDR
- Packaging → PPWR
Example: sterile packaging vs. recyclability
Conclusion
The PPWR establishes packaging as a separate compliance area with clearly defined obligations.
It is no longer only the product that matters – packaging must also meet all applicable legal requirements.
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