MedTech Europe

…www.medtecheurope.org Page 1 of 6 Review of the requirements for packaging and other measures to prevent packaging waste Feedback on the Public Consultation 21 December 2020 MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, welcomes the opportunity to contribute to the public consultation regarding the review of the requirements for packaging and other measures to prevent packaging waste. Medical devices and in vitro diagnostics save and improve people’s lives, support in the diagnosis and treatment of diseases, and keep people in good health.

…save and improve people’s lives, support in the diagnosis and treatment of diseases, and keep people in good health. The legislative framework that guarantees the safety and performance of medical devices has been recently overhauled by the adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In vitro Diagnostic medical devices (IVDR). Overall, MedTech Europe supports the broad objective to review the essential requirements of the Directive 94/62/EC on Packaging and Packaging Waste. This review aims to ensure the good functioning of the internal market through legal harmonisation on packaging. Simultaneously, it aims to tackle the negative impact that packaging as well as packaging waste could have on health and the environment. Part 3: Questions targeted at expert stakeholders Question 11.

…waste could have on health and the environment. Part 3: Questions targeted at expert stakeholders Question 11. Policy and operational objectives and related measures targeting packaging Objective 1: To increase level playing field and harmonization of requirements for products placed on the internal market: Agree Objective 2: To limit and/or reduce the packaging waste generated across the EU: Agree Objective 3: To promote the use of reusable packaging whenever logistically feasible with a view to reduce packaging waste generation: Agree Objective 4: To increase the recyclability of packaging: Agree Objective 5: Develop clear definitions of biodegradable and compostable packaging: Agree Objective 6: Harmonise the labelling of biodegradable and compostable packaging: Agree Ref.

…packaging: Agree Objective 6: Harmonise the labelling of biodegradable and compostable packaging: Agree Ref. Ares(2020)7875852 - 22/12/2020 www.medtecheurope.org Page 2 of 6 Objective 7: Set criteria for the use of compostable packaging in order to restrict the types of packaging that can be designed for composting: Undecided Objective 8: Increase the level of recycled content in packaging: Agree Objective 9: Ensure that the mechanisms to enforce compliance with the essential requirements for packaging are effective whilst minimising administrative burden: Agree

…compliance with the essential requirements for packaging are effective whilst minimising administrative burden: Agree 13. What additional EU level measure(s), if any, would you recommend to meet any of the policy objectives set out above? The medical technology industry already strives towards the use of the least possible amount of packaging to reduce the carbon footprint in the industry’s supply chain. In addition, the medical technology industry believes it is important to enabling innovation in recycling capabilities to take advantage of newer and more advanced recycling technologies.

…to enabling innovation in recycling capabilities to take advantage of newer and more advanced recycling technologies. 1) Therefore, MedTech Europe recommends some targeted measures in instances where options are limited and current provisions prevent the sector from eliminating packaging, such as: • The safeguard of shelf life, sterilisation and performance of healthcare products; • The delivery of child-resistant packaging solutions; • The preservation of the product integrity to avoid waste; and • The specific regulatory requirements for medical devices that hinder the use of: o post-consumer recycled (PCR) content in primary packaging materials; o reusable packaging for active implants; o etc.

…post-consumer recycled (PCR) content in primary packaging materials; o reusable packaging for active implants; o etc. 2) The differentiation among the types of packaging should also be considered. For example, some primary packaging interacts with instruments or devices and have a function or supports the function of an instrument, as described below: • Automatic opening and closing require an interface at the packaging for the instrument. • The piercing of some packaging needs to fulfil specific requirements. These sometimes require the use of specialised polymer composites that are not necessarily environmentally optimised.

These sometimes require the use of specialised polymer composites that are not necessarily environmentally optimised. 3) In addition, the medical technology industry supports the establishment of harmonised requirements between EU Member States on recycling systems and waste collection. We further support the distribution of responsibility among all actors in the value chain. Furthermore, MedTech Europe www.medtecheurope.org Page 3 of 6 believes that an official overview of regulated substances and applicable products, thresholds, and exemptions should be provided covering all EU legislations regarding substances. This would simplify the legal obligation of the manufacturer to comply with all different requirements.

…substances. This would simplify the legal obligation of the manufacturer to comply with all different requirements. 4) Finally, in order to support the second objective on reducing packaging waste, MedTech Europe strongly recommends that the European Commission enlarges the scope of the Regulation (EU) No 207/2012 to instructions for use for all medical devices covered by the Regulation (EU) 2017/745 that are used by professional users (i.e., healthcare professionals). The enlarged scope of this Regulation will help meet the policy objectives in the following ways: • The elimination of paper instructions for use (IFU) from each sales package. • The use of electronic IFU is likely to encourage manufacturers to use smaller sales package sizes, further reducing waste and allowing more storage space in the hospitals.

…to use smaller sales package sizes, further reducing waste and allowing more storage space in the hospitals. Electronic IFU will facilitate compliance with the Directive 2008/98/EC on waste (Waste Framework Directive). Currently, manufacturers must provide paper IFU in all official EU languages for the many device categories not falling under Regulation (EU) No 207/2012. At the same time, manufacturers can face charges and penalties for not complying with national legislation that transposes the Waste Framework Directive. Wider use of an electronic format IFU would bring alignment among the different pieces of EU and national legislations. Paper copies can still be made available free of charge at any time when requested, as envisioned currently under Regulation (EU) No 207/2012.

…be made available free of charge at any time when requested, as envisioned currently under Regulation (EU) No 207/2012. The electronic use IFU for professional users are already a common practice worldwide (USA, Canada, Brazil, Turkey, etc.) and seen to not pose any additional risks.

…are already a common practice worldwide (USA, Canada, Brazil, Turkey, etc.) and seen to not pose any additional risks. 14. Which are the most important reasons for you to have decided that you do not support specific measures above (for example loss of flexibility, administrative costs, risks, ongoing industry-led initiative will resolve the issue)? In general, MedTech Europe supports the aforementioned efforts. Equally, it is crucial to ensure that safety and product integrity are not compromised. To this end, MedTech Europe would like to note some patient safety risks stemming from: • Poor traceability (use of commercially available and viable mechanically recycled content); • The difficulty of controlling the materials and processes (loss of functional equivalency of materials leading to extensive revalidations needed for sterile medical devices; • Reassessment of the risk profile of…

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…www.medtecheurope.org Page 1 of 9 MedTech Europe Feedback on the Commission Proposal for a Regulation on Packaging and Packaging Waste (PPWR) 3 April 2023 MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices, and digital health. The medical technology sector is committed to environmental protection and is working towards continuously reducing the environmental footprint of its packaging, where feasible. Table of Contents Executive Summary 2 Introduction 3 Key Considerations 3 Annex I 6 1. Requirements for Medical Technologies: Legislation and Standards 6 2. Changes to Packaging for Medical Technologies 7 3. Verification and Validation Processes of Packaging for Medical Technologies 8

Packaging for Medical Technologies 7 3. Verification and Validation Processes of Packaging for Medical Technologies 8 4. Changes to Labels 8 About MedTech Europe 9 Ref. Ares(2023)2405316 - 03/04/2023 www.medtecheurope.org Page 2 of 9 Executive Summary The medical technology industry is keenly aware of the need to conserve resources and shift from a linear material model of extraction, use and disposal to a circular economy model. That need is expressed in international commitments like the UN Sustainable Development Goal 12, customer expectations, as well as businesses’ responsibilities and interests. MedTech Europe supports the objective of the Packaging and Packaging Waste Regulation (PPWR) proposal to prevent or reduce the adverse impacts of packaging waste on the environment and human health. We appreciate the acknowledgement of the sector's specificities and granting special…

…maintenance of its functionality. This document highlights the specific considerations of our sector, and we ask for: 1. Special consideration regarding the transition to full circularity. A minimum of a seven-year transition period for implementing the requirements applying to medical technologies' packaging will be required for the sector to develop solutions for recyclability performance, labelling and minimisation to ensure medical technologies continue to be supplied in safe and high-quality state to patients and end users. Furthermore, recycling technology is currently not sufficiently mature or scalable for robust recycling of medical packaging waste or the provision of recycled materials congruent with stringent health and safety requirements of sectorial regulation.

…or the provision of recycled materials congruent with stringent health and safety requirements of sectorial regulation. 2. Legislative consistency. The requirements should align with applicable legislation and the proposed and existing conformity assessment procedures in place under the IVDR1 and MDR2 sectorial legislation. 3. Harmonisation of the requirements. MedTech Europe welcomes the transition to a Regulation that leads to harmonisation at the EU level. It is crucial to ensure greater protection and avoid disruption of the EU Single Market by harmonising the different requirements among Member States until the new legislation enters into force.

Market by harmonising the different requirements among Member States until the new legislation enters into force. 4. Material-neutral exemption about the requirements on recyclability. Packaging for medical technologies is often made of non-plastic materials, which will also require additional time to implement the proposed recyclability requirements under Article 6 (Recyclable packaging). 5. Extension of the scope of the exemptions granted for medical technologies packaging under Article 6 (Recyclable packaging) and Article 7 (Recycled content in plastic packaging) to include similar applications for research use only and investigational devices. These exemptions should also be extended to sales packaging of critical supplies of medical technologies’ components, materials, and parts covered by MDR Article 117.

…packaging of critical supplies of medical technologies’ components, materials, and parts covered by MDR Article 117. 1 Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices 2 Regulation (EU) 2017/745 on Medical Devices www.medtecheurope.org Page 3 of 9 Introduction Medical technologies are very diverse, including a large variety of enabling technologies, materials, use environment and end users. They can be everyday objects such as sticking plasters, syringes, surgical masks, or latex gloves. They could also be spectacles, wheelchairs, COVID-19 tests, or medical apps. Medical technologies also include total body scanners, gene mutation tests, combination products3, e.g., adrenaline or insulin injectors and drug-eluting stents, implantable devices such as heart valves and pacemakers, and replacement joints for knees and hips.

…stents, implantable devices such as heart valves and pacemakers, and replacement joints for knees and hips. That is also reflected in the packaging of different medical technologies, as existing regulatory requirements are set and controlled by detailed sectorial legislation: Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), including similar applications used in research-use only 4 and investigational devices. These regulations govern medical technologies, their packaging, and accompanying information about safe disposal. Likewise, they regulate the need for packaging functionalities to minimise the risks for patients by maintaining sterility and ensuring the function of medical technologies.

…to minimise the risks for patients by maintaining sterility and ensuring the function of medical technologies. Key Considerations Transition to Full Circularity The transition to the validation of alternative materials with an adequate level of quality and quantity of stable material supply to replace existing ones takes time to safeguard materials' consistency, reliability, and biocompatibility. Conventional recycling techniques will degrade polymeric materials, and their composition will be compromised. This impedes the sector from ensuring the safety and performance requirements of the product and packaging can still be met due to a lack of control of the composition and performance of the recycled content. Virgin-like recycled material suitable for medical technology packaging will unlikely be available by 2035.

…content. Virgin-like recycled material suitable for medical technology packaging will unlikely be available by 2035. There will be a huge demand for recycled materials, and it will be difficult for Small and Medium Enterprises (SMEs), which represent 95% of more than 34,000 medical technology companies in Europe, to get such materials. The sector welcomes the exemption from mandatory recycled content requirements for contact-sensitive plastic packaging of healthcare technologies, which is necessary for patient safety. This approach must be extended to critical medical and pharmaceutical industries supplied materials.

…patient safety. This approach must be extended to critical medical and pharmaceutical industries supplied materials. Such materials include, for example, packaging components like preformed sterile barrier systems, containers, jars, syringes, cartridges, stoppers for syringes or closures for containers of critical raw materials like active pharmaceutical ingredients/excipients and critical materials for medical technologies to avoid possible contaminations. Many of these components and materials are delivered sterile for aseptic processing of parenteral, for instance, or 3 Combination products are a combination of a medicinal product and a device and have to comply with the relevant requirements of both regulatory schemes. Combination products can be co-packed or form a single integral product, as per Regulation (EU) 2017/745 Chapter I, Article 1, §8 and §9.

…can be co-packed or form a single integral product, as per Regulation (EU) 2017/745 Chapter I, Article 1, §8 and §9. 4 In vitro diagnostic medical devices can be defined as “reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, e.g., body fluids and tissue donations from organisms”. www.medtecheurope.org Page 4 of 9 packaged under very controlled conditions, and changes to these packaging will trigger revalidations and potential recertification of healthcare technologies.

…and changes to these packaging will trigger revalidations and potential recertification of healthcare technologies. Once a sufficient supply of performance and composition-stable recyclable non-plastic materials are available, the sector will need at least seven years to implement the recyclability performance of non-plastic packaging to allow for redesign, qualification, registration, and on-market performance assessment. In many cases, the sector has already been designing for recyclability and the introduction of recycled content on grouped and transport packaging. Nonetheless, these changes must also be covered by change management or recertifications which will require longer transition times.

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…1 Packaging and Packaging Waste Regulation (EU) 2025/40: Response to EC consultation on Draft Delegated Act on Reuse Target Exemptions 8 January 2025 MedTech Europe, the European trade association for the medical technology industry, including medical devices, in vitro diagnostics and digital health, welcomes the opportunity to respond to the Commission’s Call for Feedback on the draft Delegated Act on Reuse Target Exemptions pursuant to Regulation (EU) 2025/40 on Packaging and Packaging Waste. MedTech Europe shares the objectives of preventing the generation of packaging waste, boosting high quality (‘closed loop') recycling, reducing the need for primary natural resources and creating a well-functioning market for secondary raw materials while maintaining patients’ access to lifesaving and life-sustaining medical technologies.

…for secondary raw materials while maintaining patients’ access to lifesaving and life-sustaining medical technologies. Reuse Targets for Pallett Wrappings and Straps in Article 29(2) and 29(3) MedTech Europe welcomes the proposed exemptions from the reusable packaging requirements of Article 29(2) and 29(3) of Regulation (EU) 2025/40 for pallet wrappings and straps. As the assessment of the Commission has shown, “transitioning to 100% reusable pallet wrappings and straps involves high initial investments to redesign packaging lines” as well as “would require investments in automated solutions for reusable packaging which are not sufficiently developed yet”.

…as “would require investments in automated solutions for reusable packaging which are not sufficiently developed yet”. MedTech Europe further appreciates the Commission’s commitment to the latest scientific and economic data, as the October 2025 study commissioned to Deloitte indicates that applying Article 29(2) and 29(3) to pallet wrappings and straps ultimately “disrupt supply chains and lead to costs to the economic operators” as well as unintended environmental burden due to inefficient return logistics and waste disposal. This would be detrimental to the vital European healthcare systems whose patients depend on the supply and availability of medical technologies. Reuse Targets for Pallett Wrappings and Straps in Article 29(1) Manufacturers of medical technology nevertheless express their concern with Article 29(1).

…and Straps in Article 29(1) Manufacturers of medical technology nevertheless express their concern with Article 29(1). Derogations for straps and wraps should also be enacted for the requirement in Article 29 (1) in accordance with Article 29(18)(a), which empowers the Commission to establish additional exemptions for economic operators, for targets set out in Article 29(1), 29(2), 29(3), 29(5) and 29(6). The requirement of Article 29 (1) is currently too high to be feasible in many industries, including the healthcare industry. Ref. Ares(2026)234384 - 09/01/2026 2 As acknowledged in the Deloitte study, the draft Delegated Act recitals, and explanatory memorandum, the application of reuse targets to pallet wrappings and straps is technically not feasible due to the intrinsic properties of flexible formats, which loose tensile strength after use.

…technically not feasible due to the intrinsic properties of flexible formats, which loose tensile strength after use. Alternatives to single-use wrappings and straps are still in the process of being tested and perfected and thus, there are no alternatives on the market that can be scaled and provide an equal or superior performance to single-use pallet wrappings and straps. This is of particular concern in healthcare, as pallet wrappings and straps serve critical functions by ensuring product integrity and compliance with strict hygiene standards. As they are utilised to transport sterile, fragile or contamination-sensitive medical technology products, any compromise in containment through reuse can cause safety risks for patients.

…medical technology products, any compromise in containment through reuse can cause safety risks for patients. Beyond ensuring sterility of the medical technology in the transport process, packaging such as wrappings and straps also serves to ensure functionality of the product, such as chemical residual control. Reuse targets introduce new challenges and potential risks in the logistics chain with regards to the cleanliness of the reused wrappings and straps and migration of certain substances into the packaging. A clear example would be the case of leaks, which could lead to the cross-contamination of products in subsequent rotations. As a result, not all reusable wrapping and strap alternatives in the market can be used to ensure the safe handling of medical technology.

…reusable wrapping and strap alternatives in the market can be used to ensure the safe handling of medical technology. MedTech Europe therefore suggests enacting a similar exemption for pallet wrapping from the requirements established by Article 29(1), in accordance with Article 29(18)(a) of the PPWR. The Understanding of 100% Reusability Targets in Article 29(2) and 29(3) MedTech Europe would also like to express its concern towards the Commission’s understanding of the reusability rate requirements of Article 29(2) and 29(3). In Article 1 of the draft Delegated Act, the Commission quantifies the exemptions from Article 29(2) and 29(3) as being from the “100% reuse requirements”. However, this numerical quantification is not given in the legal text of the PPWR and should be adjusted.

However, this numerical quantification is not given in the legal text of the PPWR and should be adjusted. Further Medical Technology Specific Exemption Needs While MedTech Europe welcomes the proposed exemptions of the draft Delegated Act from the reusable packaging requirements, it stresses that further exemptions are necessary to reflect the sector specific health and safety needs of the medical technology industry. The legal basis of Article 29(18)(b) of the PPWR empowers the Commission to adopt Delegated Acts to establish “exemptions for specific packaging formats covered by the targets set out in paragraphs 1, 2, 3, 5 and 6 of this Article, where hygiene and food safety issues prevent the achievement of those targets”.

…1, 2, 3, 5 and 6 of this Article, where hygiene and food safety issues prevent the achievement of those targets”. Consequently, MedTech Europe recommends enacting a similar Delegated Act granting ‘contact sensitive packaging’, as described in Article 3(49) of the PPWR, an exemption from reuse obligations as set out in Article 29(1), 29(2) and 29(3), in accordance to Article 29(18)(b). ‘Contact sensitive packaging’ is defined “packaging that is intended to be used for products falling within the scope of […] Regulations (EU) 2017/745 and (EU) 2017/746” and covers packaging for medical devices and in vitro diagnostics. 3 Ensuring an exemption from reuse targets is essential for ensuring the sterility of medical technology during transport and avoiding cross contamination from medical devices and in vitro diagnostic reagents containing specialised chemical substances.

…cross contamination from medical devices and in vitro diagnostic reagents containing specialised chemical substances. If not addressed, the Article 29 reuse obligations may compromise the product’s integrity with adverse effects on patient safety. Additionally, while the medical technology sector has a long history of innovation and adaptation, including in packaging, it is imperative to stress it also is a highly regulated sector, and one that must meet the highest safety standards and regulatory approval processes according to the sector-specific MDR and IVDR. Any modifications to the packaging could trigger certain recertification obligations, a time-consuming process, encompassing not only R&D but documentation, testing, full review and approval by Notified Bodies.

…process, encompassing not only R&D but documentation, testing, full review and approval by Notified Bodies. MedTech Europe thanks the Commission for its openness to stakeholder feedback and remains available for further information. About MedTech Europe MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations that research, develop, manufacture, distribute and supply health-related technologies, services and solutions. www.medtecheurope.org. For more information, please contact: Sigrid Linher Director Sustainability and Environment [email protected]

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