Tips for meeting new European device packaging regulations

Failure to comply with European packaging waste directives could result in financial or larger penalties for device manufacturers. Get expert advice on designing devices for recyclability, using innovative materials, testing and more.

Author: Sarah Webber, Plastic Ingenuity

Packaging photo of recyclable and optimized PET pipettes from Plastic Ingenuity for Beckman Coulter Diagnostics.

Plastic Ingenuity’s recyclable and optimized PET pipette packaging for Beckman Coulter Diagnostics (photo courtesy of Plastic Ingenuity)

The European Union Packaging and Packaging Waste Regulation (PPWR) is moving through a fast-track legislative process and aims to change the EU’s approach to packaging waste and move towards a circular economy.

The Regulation is a key element of the European Green Deal, which aims to reduce greenhouse gas emissions by at least 55% by 2030 and achieve net zero emissions by 2050.

Understanding and complying with the new regulations is crucial for medical device manufacturers, as failure to comply can result in significant financial penalties or even product recalls.

With the upcoming changes in mind, it is time to start preparing.

1. Follow the example of other industries.

The food and beverage sector has a head start on sustainable packaging design, and the medical device industry can learn from them. Resources like the Association of Plastic Recyclers (APR) Design Guide and RecyClass’s Design for Recycling Guidelines provide valuable information on designing for recyclability in the consumer market.

Simple changes like reducing label size, switching to polyolefin labels, or removing harmful additives or colors can have a dramatic impact on the recyclability of a package. By adopting and adapting these proven methods, medical device manufacturers can increase packaging sustainability while complying with upcoming regulations.

2. Start with recyclable materials.

Photo of Plastic Ingenuity thermoformed PETG packaging with a Tyvek lid, the industry standard sterile barrier system for medical devices.

Plastic Ingenuity’s thermoformed PETG packaging with a Tyvek lid is the industry standard sterile barrier system for medical devices. (Photo courtesy of Plastic Ingenuity)

Medical device packaging often contains materials necessary for product sterility and safety, but these are not easily recycled.

For example, PETG (polyethylene terephthalate glycol) is a common material, and having a lower melting point than PET, PETG can contaminate the recycling stream. One innovative solution is to switch from PETG to APET (amorphous PET) materials. Certain grades of APET can withstand sterilization while still being recyclable in the PET stream. Proper testing and documentation will be key to proving APET’s recyclability and compliance with the new regulations.

By 1 January 2028, the European Commission will set a recycling efficiency class and packaging design. From 1 January 2030, packaging must meet the criteria for packaging design for recycling. While packaging for touch-sensitive medical devices is exempt from this deadline in 2030, the exemption will be reassessed in 2035.

Resources such as Design Guidance, published by the Healthcare Plastics Recycling Council, can help medical device packaging professionals make informed material choices that comply with current and anticipated recycling regulations.

3. Use recycled materials.

Recycled materials play a key role in promoting a circular economy, reducing our dependence on fossil fuel-based plastics and reducing the carbon footprint of packaging.

PPWR sets ambitious goals for incorporating recycled materials into various types of packaging:

By 2030:

30% for touch-sensitive packaging made of PET
10% for touch-sensitive packaging made of other plastics (excluding single-use beverage bottles)
30% off single-use plastic beverage bottles
35% for all other plastic packaging

By 2040:

50% for touch-sensitive packaging made of PET
25% for touch-sensitive packaging made of other plastics
65% for single-use plastic beverage bottles and other plastic packaging not covered by the previous points

The medical technology industry must develop pathways for incorporating recycled materials into sterile barrier systems (SBS). ISO 11607 (Packaging for terminally sterilized medical devices), which requires full traceability of SBS packaging materials currently excludes mechanically processed materials as a possible feedstock. However, the use of advanced recycled materials will help manufacturers meet future requirements for recycled content while still meeting this ISO standard.

Because advanced recycled materials degrade to monomer levels, their performance and integrity are equivalent to raw materials derived from virgin fossil fuels. Compliance with ISO 11607 is achieved through a mass balance approach to certify recycled content and maintain traceability. Verifiable accounting clearly tracks and documents the use of recycled versus virgin materials throughout the supply chain, providing transparency and traceability of the amount of recycled content to be reported.

4. Improve your testing and validation process.

Photo of Plastic Ingenuity team members inspecting thermoformed parts in an ISO Class 8 cleanroom.

Plastic Ingenuity team members inspect thermoformed parts in an ISO Class 8 cleanroom. (Photo courtesy of Plastic Ingenuity)

As regulations evolve, it is becoming increasingly important to integrate sustainability into packaging testing and validation processes. This includes:

Void Factor and Packaging Minimization: Even for contact sensitive medical device packaging, the requirement to minimize packaging is within scope and must be documented. The void ratio relative to the packaged product(s) must not exceed 40%. Elements not necessary for the function must be removed and weight and volume must be reduced to a minimum to ensure functionality.
Failure Point Analysis: Determine the minimum amount of material needed to maintain package integrity to reduce its carbon footprint.
Life Cycle Assessment (LCA):Conduct a life-cycle analysis (LCA) to assess the environmental impact of your packaging and identify opportunities to reduce material usage without compromising performance.
Evaluation of recyclable materials:Test new recyclable materials through validation protocols to ensure they meet regulatory requirements and performance standards.

Take advantage of re-verification and re-validation activities undertaken by regulators by incorporating package design changes into verification and validation procedures.

5. Stay up to date with labeling requirements.

Correct labelling for disposal by the end consumer will be essential for compliance with the PPWR.

From 42 months after the entry into force of the regulation, packaging must include a label with information on the material composition. The harmonized logo and formats of these labels will be provided 18 months after entry into force.

Stay current on these requirements and adjust your labeling practices as new guidelines emerge.

Photo by Sarah Webber, Sustainable Packaging Engineer at Plastic Ingenuity

Sarah Webber (Photo courtesy of Plastic Ingenuity)

Sarah Webber is a Sustainable Packaging Engineer at Plastic Ingenuity with experience in medical device packaging development, packaging performance testing, design for recyclability, and life cycle assessments. She is a member of the Healthcare Plastics Recycling Council, the Institute of Packaging Professionals – Sustainable Packaging Technical Committee, and the Design Collaborative Steering Committee of the Sustainable Packaging Coalition.

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The views expressed in this blog post are the author’s own and do not necessarily reflect the views of Medical Design & Outsourcing or its employees.