PPWR applies today: what it asks of medical device packaging
The EU Packaging Regulation applies from today. Which derogations are real, and why February 2028 matters more than 2030.
The Packaging and Packaging Waste Regulation, Regulation (EU) 2025/40, applies from today. It entered into force on 11 February 2025 and repeals Directive 94/62/EC. Packaging rules now come from one regulation that applies directly in every Member State (Article 71Article 71This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 12 August 2026.However, Article 67(5) shall apply from 12 February 2029.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.).
Two reactions are common in our industry. The first is that nothing changes for years. The second is that medical devices are exempt.
The first is wrong by about two years. Everyone is watching 2030. The date that decides your carton is February 2028.
The second is wrong in a more interesting way. The derogations are real and they are written down. They are also much narrower than most people assume.
Two details settle the scope question. Article 2(1)Article 2(1)This Regulation applies to all packaging, regardless of the material used, and to all packaging waste, whether such packaging is used in or such packaging waste originates from industry, other manufacturing, retail or distribution, offices, services or households.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. says the regulation applies to all packaging, regardless of the material used. There is no sectoral exclusion anywhere in the text. And Annex IAnnex IA. Article 3(1), point (1)(a)1.Items that are packaging: Sweet boxes Film overwrap around a CD case Mailing pouches for catalogues and magazines (with a magazine inside) Cake doilies sold with a cake Rolls, tubes and cylinders around which flexible material (e.g. plastic film, aluminium or paper) is wound, except rolls, tubes and cylinders intended as parts of production machinery and not used to present a product as a sales unit Flower and plant pots, including seed trays, intended to be used only for selling and transporting Glass bottles for injection solutions CD spindles (sold with CDs, not intended to be used as storage) Clothes hangers (sold with a clothing item) Matchboxes Sterile barrier systems (pouches, trays and materials necessary to preserve the sterility of the product) Refillable steel cylinders used for various kinds of gas, excluding fire extinguishers Tea and coffee foil pouches Boxes used for toothpaste tubes2.Items that are not packaging: Flower and plant pots, including seed trays, used in business-to-business relations throughout different stages of production or intended to be sold with the plant Tool boxes Wax layers around cheese Sausage casing skins Clothes hangers (sold separately) Cartridges for printers CD, DVD and video cases (sold together with a CD, DVD or video inside) CD spindles (sold empty, intended to be used as storage) Soluble bags for detergents Graveside lights (containers for candles) Mechanical quern (integrated in a refillable recipient, e.g. refillable pepper mill)B. Article 3(1), points (1)(b) and (c)1.Items that are packaging: Labels hung directly on or attached to a product including sticky labels attached to fruits and vegetables Mascara brush which forms part of the container closure Sticky labels attached to another packaging item Staples Plastic sleeves Device for measuring dosage, which forms part of the container closure for detergents Mechanical quern (integrated in a non-refillable recipient, filled with a product, e.g. pepper mill filled with pepper)2.Items that are not packaging: Radio frequency identification (RFID) tags Tyre labels in the form of stickers in accordance with Regulation (EU) 2020/740 of the European Parliament and of the Council (1)C. Article 3(1), points (1)(d) and (e)1.Items that are packaging, if designed and intended to be filled at the point of sale: Paper or plastic carrier bags Disposable plates and cups Cling film Sandwich bags Aluminium foil Plastic foil for cleaned clothes in laundries2.Items that are not packaging: Stirrer Disposable cutlery Wrapping paper (sold separately to consumers and business operators) Paper baking cases (sold empty) Cake doilies sold without a cake Disposable plates and cups not intended to be filled at the point of salePPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected., which lists what counts as packaging, names sterile barrier systems explicitly: pouches, trays and materials necessary to preserve the sterility of the product. Your sterile barrier is not outside this regulation. It is named inside it.
Article 2(2)Article 2(2)This Regulation applies without prejudice to the provisions of Directive 2008/98/EC as regards the management of hazardous waste as well as to Union regulatory requirements for packaging such as those for safety, quality, the protection of health and the hygiene of packed products, and to transport requirements. However, where this Regulation conflicts with Directive 2008/68/EC, Directive 2008/68/EC shall prevail.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. is the one people mistake for an exemption. It says the regulation applies without prejudice to Union requirements on the safety, quality, health protection and hygiene of packed products. That protects your MDR obligations from being overridden. It does not release your packaging from this regulation.
The dates that matter
Today, 12 August 2026. The regulation applies. The sum of lead, cadmium, mercury and hexavalent chromium in packaging is capped at 100 mg/kg (Article 5(4)Article 5(4)Without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004, the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). PFAS limits also start today, but they cover food-contact packaging only, so they do not reach device packaging (Article 5(5)Article 5(5)From 12 August 2026, food-contact packaging shall not be placed on the market if it contains per- and polyfluorinated alkyl substances (PFAS) in a concentration equal to or above the following limit values to the extent that the placing on the market of packaging containing such a concentration of PFAS is not prohibited pursuant to another Union legal act:‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it), except substances that only contain the following structural elements: CF3-X or X-CF2-X′, where X = -OR or -NRR′ and X′ = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR′′, -SR′′ or –NR′′R′′′; and where R/R′/R′′/R′′′ is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).By 12 August 2030, the Commission shall carry out an evaluation to assess the need to amend or repeal this paragraph in order to avoid overlaps with restrictions or prohibitions on the use of PFAS laid down in accordance with Regulations (EC) No 1935/2004, (EC) No 1907/2006, or (EU) 2019/1021.(a) 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification);(b) 250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis, where applicable with prior degradation of precursors (polymeric PFAS excluded from quantification); and(c) 50 ppm for PFASs (including polymeric PFAS); if total fluorine exceeds 50 mg/kg the manufacturer, importer or downstream user as defined respectively in Article 3, points (9), (11) and (13) of Regulation (EC) No 1907/2006 shall, upon request, provide to the manufacturer or the importer as defined respectively in Article 3(1), points (13) and (17), of this Regulation proof of the quantity of fluorine measured as content of either PFAS or non-PFAS in order for them to draw up the technical documentation as referred to in Annex VII to this Regulation.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Conformity assessment against Articles 5 to 12 follows Annex VIIAnnex VIIA. Internal production control1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 and ensures and declares on his sole responsibility that the packaging concerned satisfies the requirements of Articles 5 to 12 of this Regulation that apply to it.2. Technical documentationThe manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the packaging’s conformity with the applicable requirements, and shall include an adequate analysis and assessment of the risks of non-conformity.The technical documentation shall specify the applicable requirements and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging. The technical documentation shall contain, wherever applicable, at least the following elements:(a) a general description of the packaging and its intended use;(b) conceptual design, manufacturing drawings and materials of components;(c) descriptions and explanations necessary for the understanding of the drawings provided under point (b) and the schemes and operation of the packaging;(d) a list of: (i) the harmonised standards, referred to in Article 36, applied in full or in part; (ii) the common specifications, referred to in Article 37, applied in full or in part; (iii) other relevant technical specifications used for measurement or calculation purposes; (iv) in the event of partly applied harmonised standards or common specifications, an indication of the parts which have been applied; (v) in the event of harmonised standards or common specifications not being applied, a description of the solutions adopted to meet the requirements referred to in point 1;(e) a qualitative description of how the assessments provided for in Articles 6, 10 and 11 have been carried out; and(f) test reports.3. ManufacturingThe manufacturer shall take all measures necessary so that the manufacturing process and the monitoring thereof ensure compliance of the manufactured packaging with the technical documentation referred to in point 2 and with the requirements referred to in point 1.4. Declaration of conformityThe manufacturer shall draw up a written declaration of conformity for each packaging type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after single-use packaging has been placed on the market, and 10 years after reusable packaging has been placed on the market. The declaration of conformity shall identify the packaging for which it has been drawn up.A copy of the declaration of conformity shall be made available to the relevant authorities upon request.5. Authorised representativeThe manufacturer’s obligations set out in point 4 as regards keeping the technical documentation may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that those obligations are specified in the mandate.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected., with an EU declaration of conformity (Articles 38Article 38Conformity assessment of packaging as regards the requirements laid down in or pursuant to Articles 5 to 12 shall be carried out in accordance with the procedure set out in Annex VII.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. and 39Article 391. The EU declaration of conformity shall state that the fulfilment of the requirements laid down in or pursuant to Articles 5 to 12 has been demonstrated.2. The EU declaration of conformity shall have the model structure set out in Annex VIII, contain the elements specified in the module set out in Annex VII and be continuously updated. It shall be drawn up in, or translated into, one or more languages required by the Member State in which the packaging is placed on the market or made available on the market.3. Where packaging or the packaged product are subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall, where appropriate, be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. The declaration may consist of a dossier made up of relevant individual EU declarations of conformity.4. By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the packaging with the requirements laid down in this Regulation.5. Competent authorities shall endeavour to control the accuracy of at least part of the declarations of conformity per year, assessed on a risk-based approach and shall take the necessary measures to address non-compliance, such as the withdrawal of non-compliant products from the market.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Producer registration and extended producer responsibility apply with no carve-out for medical devices (Articles 44Article 441. Each Member State shall, within 18 months of the date of entry into force of first implementing act adopted pursuant to paragraph 14, establish a national register which shall serve to monitor compliance of producers with the requirements set out in this Chapter.Each national register shall provide links to other national registers of producers’ websites to facilitate, in all Member States, registration of producers or authorised representatives for the extended producer responsibility.2. Producers shall be obliged to register in the register referred to in paragraph 1 of this Article in each Member State where they make packaging or packaged products available on the territory of the Member State for the first time or where they unpack packaged products without being end users, by submitting an application for registration to the competent authority responsible for the register of each such Member State. Where a producer has entrusted a producer responsibility organisation with carrying out the extended producer responsibility obligations on its behalf pursuant to Article 46(1), the obligations set out in this Article shall be met by that organisation, unless otherwise specified by the Member State in which the register is established.3. Member States may provide that the obligations set out in this Article may, on the basis of a written mandate, be met on behalf of producers by an authorised representative for the extended producer responsibility.4. Producers shall not make available packaging or packaged products on the territory of a Member State for the first time, or unpack packaged products without being end users, if they or, where applicable, in accordance with Article 45, their authorised representatives for the extended producer responsibility are not registered in that Member State.5. The application for registration shall include the information to be provided in accordance with Part A of Annex IX. A Member State may request producers to provide additional information or documents if such information or documents are necessary to monitor and ensure compliance with this Regulation and with the rules adopted by that Member State pursuant to Article 40(2).6. Where an authorised representative for the extended producer responsibility represents more than one producer, it shall, in addition to the information to be provided pursuant to paragraph 5, provide the name and the contact details of each one of the producers which it represents, separately.7. The producer or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation, as stipulated by national law in accordance with paragraphs 2 and 3 of this Article, shall submit the information set out in Part B, point 1, of Annex IX to the competent authority responsible for the register, by 1 June for each full preceding calendar year.Member States may require the information provided pursuant to this paragraph to be audited and certified by independent auditors under the supervision of the competent authorities referred to in Article 40(1), on the basis of national standards, if any.8. Where a producer has made available for the first time on the territory of the Member State a quantity of packaging, including packaging of packaged products, of less than 10 tonnes during one calendar year, or where a producer as defined in Article 3(1), point (15)(e), unpacks a quantity of packaging of less than 10 tonnes during one calendar year, the producer or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation, as stipulated by national law in accordance with paragraphs 2 and 3 of this Article, shall submit the information set out in Part B, point 2, of Annex IX to the competent authority responsible for the register, by 1 June for each full preceding calendar year.By way of derogation from the first subparagraph, a Member State may, for a specific calendar year, set a lower maximum threshold than that referred to in the first subparagraph if the Member State would otherwise have insufficient accurate data in order to:(a) comply with the reporting obligations under Article 56(1) and (2) in that calendar year; and(b) ensure that the database under Article 57 is complete and provide the data under Article 56(2), point (a).9. If it is necessary for budgetary reasons, a Member State may require the producer to submit the information set out in Part B, points 1 and 2, of Annex IX to the competent authority responsible for the register on a quarterly basis.10. Producers, in the case of individual fulfilment of extended producer responsibility obligations, the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, or the re-use system operators, in the case where re-use systems are fulfilling the extended producer responsibility obligations, shall submit the information set out in Part B, point 3, of Annex IX to the competent authority for each preceding calendar year on an annual basis.Where under national law public authorities are responsible for the organisation of the management of packaging waste, Member States may provide that those authorities shall submit the information set out in Part B, point 3, of Annex IX.11. The competent authority responsible for the register:(a) shall receive applications for registration as referred to in paragraph 2 via an electronic data-processing system, the details of which shall be made available on the competent authority’s website;(b) shall grant registrations and provide a registration number within a maximum period of twelve weeks from the moment that all the information required under paragraphs 5 and 6 is provided;(c) may lay down modalities with respect to the requirements and process of registration without adding substantive requirements to those laid down in paragraphs 5 and 6;(d) may charge producers cost-based and proportionate fees for the processing of applications for registration as referred to in paragraph 2;(e) shall receive and monitor the information submitted pursuant to paragraphs 7 and 8.12. The producer, or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation shall, without undue delay, notify the competent authority of any changes to the information contained in the registration and of any permanent cessation of the making available for the first time on the territory of the Member State of the packaging or packaged product referred to in the registration. A producer shall be removed from the register 3 years from the end of the calendar year in which the producer’s registration ends if the producer has ceased to exist as a producer.13. Member States shall ensure that the list of registered producers is easily accessible, publicly available and free of charge, without prejudice to the preservation of the confidentiality of commercially sensitive information in conformity with the relevant Union and national law. The list of registered producers shall be machine readable, sortable and searchable, and shall respect open standards for third-party use.14. The Commission shall, by 12 February 2026, adopt implementing acts establishing the format for registration in, and reporting to, the register and specifying the granularity of data to be provided and the packaging types and material categories to be covered by the information submitted.The format for the submission of information pursuant to this Article shall be interoperable, shall be based on open standards and machine-readable data, and shall be transferable through an interoperable data exchange network without vendor lock-in.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. and 45Article 451. Producers shall have extended producer responsibility under the schemes established in accordance with Articles 8 and 8a of Directive 2008/98/EC and with this Section for the packaging, including packaging of packaged products, that they make available for the first time on the territory of a Member State or that they unpack without being end users.2. In addition to the costs referred to in Article 8a(4), point (a), of Directive 2008/98/EC, the financial contributions paid by the producer shall cover the following costs:The costs to be covered shall be established in a transparent, proportional, non-discriminatory and efficient way.(a) costs of labelling waste receptacles for the collection of packaging waste as referred to in Article 13 of this Regulation; and(b) costs of carrying out compositional surveys of collected mixed municipal waste under Commission Implementing Regulation (EU) 2023/595 (74) and under the implementing acts to be adopted pursuant to Article 56(7), point (a), of this Regulation where those implementing acts provide for an obligation to carry out such surveys.3. A producer referred to in Article 3(1), point (15)(c) and (d), shall appoint, by written mandate, an authorised representative for the extended producer responsibility in each Member State where the producer makes packaging or packaged products available for the first time, other than the Member State where the producer is established. Member States may provide that producers established in third countries shall appoint, by written mandate, an authorised representative for the extended producer responsibility when making packaging or packaged products available on their territory for the first time.4. For the purposes of compliance with Article 30(1), points (d) and (e), of Regulation (EU) 2022/2065, providers of online platforms that fall within the scope of Section 4 of Chapter III of that Regulation and that allow consumers to conclude distance contracts with producers shall obtain the following information from producers that offer packaging or packaged products to consumers located in the Union prior to allowing those producers to use their services:Where a producer sells its products via an online marketplace, the obligations set out in paragraph 2 of this Article may, on the basis of written mandate, be met by the provider of the online platform, on behalf of the producer.(a) information on the registration of the producers referred to in Article 44 of this Regulation in the Member State where the consumer is located and the registration number(s) of the producer in that register;(b) a self-certification by the producer confirming that it only offers packaging with regard to which the extended producer responsibility requirements referred to in paragraphs 1, 2 and3 of this Article are complied with in the Member State where the consumer is located.5. Member States may provide that, where automated data reconciliation with the national register is provided for in that Member State, it shall be applicable for verification of the information referred to in paragraph 4, points (a) and (b).6. Upon receiving the information referred to in paragraph 4 and prior to allowing producers to use its services, the provider of the online platform shall make best efforts to assess whether the information received is complete and reliable.7. Producers offering packaging or packaged products to consumers located in the Union shall provide fulfilment service providers with the information referred to in paragraph 4, points (a) and (b), of this Article at the moment of the conclusion of the contract between the fulfilment service provider and the producer for any of the services referred to in Article 3, point (11), of Regulation (EU) 2019/1020.8. Upon receiving the information referred to in paragraph 7of this Article and at the moment of the conclusion of the contract between the fulfilment service provider and the producer for any of the services referred to in Article 3, point (11), of Regulation (EU) 2019/1020, the fulfilment service provider shall, through the use of any freely accessible official online database or online interface made available by a Member State or the Union or by means of the publicly available registration list under Article 44(13) of this Regulation or requests to the producer to provide supporting documents from reliable sources, make best efforts to assess whether the information referred to in paragraph 7 of this Article is reliable and complete. For the purposes of this Regulation, producers shall be responsible for the accuracy of the information provided.Where the fulfilment service provider obtains sufficient indications or has reason to believe that any item of information referred to in paragraph 7 obtained from the producer concerned is inaccurate, incomplete or not up-to-date, that fulfilment service provider shall request that the producer remedies that situation without delay or within the period set by Union or national law, as applicable.Where the producer fails to correct or complete that information, the fulfilment service provider shall swiftly suspend the provision of its service to that producer in relation to the offering of packaging or packaged products to consumers located in the Union until the request has been fully complied with. The fulfilment service provider shall provide the producer with the reasons for the suspension.9. Without prejudice to Article 4 of Regulation (EU) 2019/1150 of the European Parliament and of the Council (75), in the event that a fulfilment service provider suspends the provision of its services pursuant to paragraph 8 of this Article, the producer concerned shall have the right to challenge the decision of the fulfilment service provider before a court in a Member State in which the fulfilment service provider is established.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.).
12 February 2028. This is the date to put in the plan. By then, anyone filling sales packaging must reduce empty space to the minimum necessary for the packaging to do its job, including protecting the product (Article 24(4)Article 24(4)By 12 February 2028, the economic operators who fill sales packaging shall ensure that empty space is reduced to the minimum necessary for ensuring the packaging functionality, including product protection. The empty space ratio for sales packaging shall mean the difference between the total internal volume of the sales packaging and the volume of the packaged product.For the purpose of assessing compliance with this paragraph, space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space.For sales packaging for products that are subject to settlement during transportation or where headspace is required to protect the food product, or other products that present these characteristics:(a) compliance with this paragraph shall be assessed as the pack-fill level at the time of filling;(b) air between or within packed foodstuff or protective gases shall not be considered as empty space.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Your device carton is sales packaging. This duty does not wait for an implementing act. It does not wait for 2030 either.
12 August 2028. Harmonised labelling of material composition (Article 12(1)Article 12(1)From 12 August 2028 or 24 months from the date of entry into force of the implementing acts adopted pursuant to paragraphs 6 or 7 of this Article, whichever is the latest, packaging placed on the market shall be marked with a harmonised label containing information on its material composition in order to facilitate consumer sorting. The label shall be based on pictograms and be easily understandable, including for persons with disabilities. For the packaging referred to in Article 9(1) and, where applicable, packaging referred to in Article 9(2), the label shall indicate that the material is compostable, that it is not suitable for home composting and that compostable packaging is not to be discarded in nature. With the exception of e-commerce packaging, this obligation does not apply to transport packaging or to packaging that is subject to a deposit and return system.The packaging placed on the market containing substances of concern shall be marked by means of standardised, open, digital-marking technologies in accordance with the methodology referred to in paragraph 7, second subparagraph.In addition to the harmonised label referred to in this paragraph, economic operators may place a QR code or other type of standardised, open, digital data carrier on the packaging that contains information on the destination of each separate component of the packaging in order to facilitate consumer sorting.Packaging that is subject to deposit and return systems as referred to in Article 50(1) shall be marked with a clear and unambiguous label. In addition to the national label, packaging may be marked with a harmonised colour label established in the relevant implementing act adopted pursuant to paragraph 6 of this Article. Member States may require that packaging that is subject to deposit and return systems be marked with that harmonised colour label, provided that that does not lead to distortions on the internal market or trade barriers for products from other Member States.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). The date moves if the implementing acts come late, because it is the later of August 2028 and 24 months after those acts. Device packaging has a conditional carve-out here, and transport packaging is left out of labelling altogether. Both are in the list at the end of the next section.
1 January 2030 at the earliest. Packaging must be designed so that its weight and volume are reduced to the minimum necessary for it to function (Article 10(1)Article 10(1)By 1 January 2030, the manufacturer or importer shall ensure that the packaging placed on the market is designed so that its weight and volume is reduced to the minimum necessary to ensure its functionality, taking account of the shape and material from which the packaging is made.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Grouped, transport and e-commerce packaging gets a cap of 50 % empty space (Article 24(1)Article 24(1)By 1 January 2030 or 3 years from the entry into force of the implementing acts adopted pursuant to paragraph 2, whichever is the latest, economic operators who fill grouped packaging, transport packaging or e-commerce packaging shall ensure that the maximum empty space ratio, expressed as a percentage, is 50 %.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Read that second one carefully. It starts on 1 January 2030, or three years after the calculation methodology is adopted, whichever comes later. The Commission has until 12 February 2028 to adopt that methodology. So 2030 is the earliest date, not the date.
One rule runs through both empty space duties. Filling materials do not count as contents. Paper cuttings, air cushions, bubble wrap, sponge and foam fillers, wood wool and polystyrene chips all count as empty space (Article 24(3)Article 24(3)For the purpose of the calculation of the ratio referred to in paragraph 1:Space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space.(a) empty space shall mean the difference between the total volume of grouped packaging, transport packaging or e-commerce packaging and the volume of sales packaging contained therein;(b) empty space ratio shall mean the ratio of the empty space as defined in point (a) and the total volume of the grouped packaging, transport packaging or e-commerce packaging.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. and (4)Article 24(4)By 12 February 2028, the economic operators who fill sales packaging shall ensure that empty space is reduced to the minimum necessary for ensuring the packaging functionality, including product protection. The empty space ratio for sales packaging shall mean the difference between the total internal volume of the sales packaging and the volume of the packaged product.For the purpose of assessing compliance with this paragraph, space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space.For sales packaging for products that are subject to settlement during transportation or where headspace is required to protect the food product, or other products that present these characteristics:(a) compliance with this paragraph shall be assessed as the pack-fill level at the time of filling;(b) air between or within packed foodstuff or protective gases shall not be considered as empty space.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.).
What this means pack by pack
The carve-outs are easier to hold if you stop reading them as a list of articles and sort them onto the packs you actually ship. The regulation recognises four layers, and they are not treated alike.
Your sterile barrier, the pouch or tray. In scope, and named in Annex I. It is contact-sensitive packaging, so it escapes the recyclability requirements (Article 6(11)Article 6(11)This Article shall not apply to the following:(a) immediate packaging as defined in Article 1, point (23), of Directive 2001/83/EC and in Article 4, point (25), of Regulation (EU) 2019/6;(b) contact-sensitive packaging of medical devices covered by Regulation (EU) 2017/745;(c) contact-sensitive packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;(d) outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC and in Article 4, point (26), of Regulation (EU) 2019/6 in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product;(e) contact-sensitive packaging for infant formula and follow-on formula, processed cereal-based food and baby food, and food for special medical purposes as defined in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013;(f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC;(g) sales packaging made from lightweight wood, cork, textile, rubber, ceramic, porcelain or wax; however, paragraph 8 shall apply to such packaging.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.) and, if it is plastic, the recycled content requirements (Article 7(4)Article 7(4)Paragraphs 1 and 2 shall not apply to the following:(a) immediate packaging as defined in Article 1, point (23), of Directive 2001/83/EC and in Article 4, point (25), of Regulation (EU) 2019/6;(b) contact-sensitive plastic packaging of medical devices, devices exclusively destined for research use and investigational devices covered by Regulation (EU) 2017/745;(c) contact-sensitive plastic packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;(d) outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC and in Article 4, point (26), of Regulation (EU) 2019/6 in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product;(e) compostable plastic packaging;(f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC;(g) contact-sensitive plastic packaging for food that is intended only for infants and young children, food for special medical purposes and packaging for drinks and food typically used for young children as referred to in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013;(h) packaging of supplies, components and immediate packaging components for the manufacturing of medicinal products covered by Directive 2001/83/EC and veterinary medicinal products covered by Regulation (EU) 2019/6, where such packaging is needed to be in line with the quality standards of the medicinal product.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Everything else lands on it: substance limits, minimisation, conformity assessment, the declaration of conformity, and EPR fees on its weight.
Your carton, the sales unit. Nothing is lifted here. This is the pack the regulation is strictest with. Empty space cut to the minimum from 12 February 2028 (Article 24(4)), minimisation from 1 January 2030 (Article 10Article 101. By 1 January 2030, the manufacturer or importer shall ensure that the packaging placed on the market is designed so that its weight and volume is reduced to the minimum necessary to ensure its functionality, taking account of the shape and material from which the packaging is made.2. The manufacturer or importer shall ensure that packaging which does not comply with the performance criteria set out in Annex IV of this Regulation and packaging with characteristics that aim only to increase the perceived volume of the product, including double walls, false bottoms and unnecessary layers, is not placed on the market, unless:(a) the packaging design is protected by a Community design pursuant to Council Regulation (EC) No 6/2002 (64) or by design rights falling within the scope of Directive 98/71/EC of the European Parliament and of the Council (65), including international agreements having effect in one of the Member States, or its shape is a trademark falling within the scope of Regulation (EU) 2017/1001 of the European Parliament and of the Council (66) or Directive (EU) 2015/2436 of the European Parliament and of the Council (67), including trademarks registered under international agreements having effect in one of the Member States, the design rights and trademarks are protected before 11 February 2025, and the application of the requirements under this Article would affect the packaging design in a way that it would alter its novelty or its individual character, or would affect the trademark in a way that the trademark is no longer capable of distinguishing the marked product from those of other undertakings; or(b) the packaged product or beverage benefits from a geographical indication protected under Union law, such as under Regulation (EU) No 1308/2013 for wine, Regulation (EU) 2019/787 for spirit drinks or Regulation (EU) 2023/2411 for craft and industrial products, or is covered by a quality scheme as referred to in Regulation (EU) 2024/1143.3. By 12 February 2027, the Commission shall request the European standardisation organisations to prepare or update, as appropriate, harmonised standards laying down the methodology for the calculation and measurement of compliance with the requirements concerning packaging minimisation under this Regulation. For most common packaging types and formats, such standards should specify maximum adequate weight and volume limits, and, where appropriate, wall thickness and maximum empty space.4. Compliance with the requirements set out in paragraphs 1 and 2 of this Article shall be demonstrated in the technical documentation referred to in Annex VII, which shall contain the following elements:For reusable packaging, the assessment of compliance with the requirements set out in paragraph 1 of this Article shall take into account the characteristics of reusable packaging, and in the first place the requirements set out in Article 11.(a) an explanation of the technical specifications, standards and conditions used to assess the packaging against the performance criteria and methodology set out in Annex IV;(b) for each of those performance criteria, the identification of the design requirements which prevent further reduction of the packaging weight or volume;(c) any test results, studies or other relevant sources, such as modelling and simulations, used to assess the minimum necessary volume or weight of the packaging.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.), harmonised material labelling from August 2028 (Article 12(1)), plus documentation and EPR. If your device reaches the buyer as a carton, this is where the work is.
Your grouped packaging, the shelf or restocking unit. Minimisation applies. The 50 % empty space cap applies from 2030 at the earliest (Article 24(1)). Labelling applies, because the exclusion for transport packaging does not reach grouped packaging.
Your transport packaging, the shipping case. Minimisation applies, and so does the 50 % cap. Labelling does not: Article 12(1) excludes transport packaging, unless it is e-commerce packaging, which is transport packaging used for distance selling. One more relief sits here. Custom-made transport packaging for configurable devices and medical systems, used in industrial or healthcare environments, also escapes conformity assessment, the technical documentation and the declaration of conformity (Article 15(11)Article 15(11)Paragraphs 2 and 3 shall not apply to custom-made transport packaging for configurable medical devices and medical systems that are to be used in industrial and healthcare environments.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.).
One condition cuts across all of them. The labelling requirements do not apply to immediate and outer packaging under the MDR and IVDR where there is genuinely no space left because of other labelling requirements (Article 12(11)Article 12(11)This Article shall not apply to immediate and outer packaging as defined in Regulations (EU) 2017/745, (EU) 2017/746 and (EU) 2019/6 and Directive 2001/83/EC, if there is no space on the packaging due to other labelling requirements as defined in those Union legislative acts or if the labelling of the packaging could jeopardise the safe use of medicinal products for human use or of veterinary medicinal products.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). That is judged pack by pack, not claimed once for a product family.
No other EU law rescues you either. Article 2(2) names exactly one act that prevails over this regulation in a conflict, and it is Directive 2008/68/EC on the inland transport of dangerous goods. The Single-Use Plastics Directive is treated as more specific than PPWR within its own scope. But that scope is carrier bags, cups and food and beverage containers. It is also stricter rather than softer. The Waste Framework Directive runs the other way: PPWR is the more specific law for extended producer responsibility, so PPWR wins. And the MDR and the IVDR are silent on packaging waste. Neither mentions it once. They govern your packaging for safety, sterility and labelling, and they never touch its environmental design.
So, the short version. Five reliefs can apply to your packaging. Four of them name medical devices or IVDs in the text, usually in the same breath as medicinal products and infant food. The fifth is a general rule that happens to help you.
- Recyclability does not apply to the sterile barrier and other contact-sensitive device packaging (Article 6(11)).
- Recycled content does not apply to that same packaging where it is plastic (Article 7(4)).
- Conformity assessment, the technical documentation and the declaration of conformity do not apply to custom-made transport packaging around configurable devices and medical systems (Article 15(11)).
- Labelling does not apply to immediate and outer packaging where other labelling requirements have left no room (Article 12(11)).
- Labelling also does not apply to transport packaging generally, unless it is e-commerce packaging (Article 12(1)). This is the general one. It applies to every industry, not only ours.
Everything else applies in full, on every layer. A sterile barrier system justifies your choice of material. It does not justify the air around it.
The test you will have to pass
Article 24(4) defines empty space in sales packaging in one line. It is the total internal volume of the packaging minus the volume of the packaged product.
Read that again if your carton holds anything besides the device. The benchmark is the product. Not the product plus everything you have always put in the box with it.
Article 10 then asks you to write down your reasoning. Packaging that fails the performance criteria in Annex IVAnnex IVA. Performance criteria1.Product protection: packaging design shall ensure protection of the product, from the point of packaging or filling until its end use, with a view to preventing significant product damage, loss, deterioration or waste. Requirements may consist of protection against mechanical or chemical damage, vibration, compression, humidity, moisture loss, oxidation, light, oxygen, microbiological infection, pest, deterioration of organoleptic properties, etc. and include references to specific Union law setting out requirements on product quality.2.Packaging manufacturing processes: the packaging design shall be compatible with the packaging manufacturing and filling processes. The packaging manufacturing processes may determine packaging design elements, such as the shape of a container, thickness tolerances, size, feasibility of tooling, or specifications minimising waste in manufacturing. The processes operated by manufacturer of products may also require certain design elements of packaging, such as impact and stress resistance, mechanical strength, packing line speed and efficiency, stability in conveying, heat resistance, effective closing, minimum headspace, or hygiene.3.Logistics: the packaging design shall ensure adequate and safe distribution, transport, handling and warehousing of the packaged product. Requirements may consist of dimensional coordination for optimum space utilisation, compatibility with palletising and de-palletising systems, handling and warehousing system, and packaging system integrity during transport and handling.4.Packaging functionality: the packaging design shall ensure its functionality, taking into account the purpose of the product and particularities giving rise to its sale, such as sales for gift purposes, or on the occasion of seasonal events.5.Information requirements: the packaging design shall ensure that any necessary information regarding the packaged product itself, its use, storage and care, including safety instructions, can be provided to end users. Requirements may include providing product information, instructions for storage, application and use, bar codes and the best before date.6.Hygiene and safety: the packaging design shall ensure user and consumer safety as well as product safety and hygiene throughout the distribution, end use and disposal of the packaged product. Requirements may include those on safe handling design, child resistance, anti-tamper, anti-theft, anti-counterfeit, hazard warnings, clear identification of content, safe opening device or pressure-release closure.7.Legal requirements: the packaging design shall ensure that the packaging and packaged product can comply with applicable law.8.Recycled content, recyclability and re-use: the packaging design shall ensure reusability, recyclability and inclusion of recycled content as required under this Regulation. If the packaging is intended for re-use, it shall fulfil the requirements laid down in Article 11(1). This means that the packaging weight or volume may have to be increased beyond what would otherwise be possible under the other performance factors in order to enable for example a higher number of trips or rotations, to facilitate inclusion of recycled content or to enhance recyclability (for example when moving to a mono-material or post-consumer recycled content).B. Assessment methodology and determination of the minimum packaging volume and weightThe assessment of the minimum packaging volume and weight necessary to ensure the packaging functionality as described in Article 3(1), point (1), shall be explained in the technical documentation and shall include at least:(a) the description of the outcome of the assessment, including the details of the calculation of the minimum necessary weight and volume for the packaging; possible variations between production batches for a same packaging shall be taken into account and documented;(b) for each performance criterion as listed in Part A, a description which explains the design requirement that prevents further reduction of the packaging weight or volume without endangering the packaging functionality, including safety and hygiene, for the packaged product, packaging and user; the method used for the identification of these design requirements shall be described, and the reasons preventing further reduction of the packaging weight or volume shall be explained; all reduction opportunities with a given packaging material shall be investigated, such as the reduction of any superfluous layer which does not perform a packaging function; substitution of one packaging material with another shall not be considered sufficient;(c) any test results, market research or studies that have been used for the assessment conducted under points (a) and (b).PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. may not be placed on the market (Article 10(2)Article 10(2)The manufacturer or importer shall ensure that packaging which does not comply with the performance criteria set out in Annex IV of this Regulation and packaging with characteristics that aim only to increase the perceived volume of the product, including double walls, false bottoms and unnecessary layers, is not placed on the market, unless:(a) the packaging design is protected by a Community design pursuant to Council Regulation (EC) No 6/2002 (64) or by design rights falling within the scope of Directive 98/71/EC of the European Parliament and of the Council (65), including international agreements having effect in one of the Member States, or its shape is a trademark falling within the scope of Regulation (EU) 2017/1001 of the European Parliament and of the Council (66) or Directive (EU) 2015/2436 of the European Parliament and of the Council (67), including trademarks registered under international agreements having effect in one of the Member States, the design rights and trademarks are protected before 11 February 2025, and the application of the requirements under this Article would affect the packaging design in a way that it would alter its novelty or its individual character, or would affect the trademark in a way that the trademark is no longer capable of distinguishing the marked product from those of other undertakings; or(b) the packaged product or beverage benefits from a geographical indication protected under Union law, such as under Regulation (EU) No 1308/2013 for wine, Regulation (EU) 2019/787 for spirit drinks or Regulation (EU) 2023/2411 for craft and industrial products, or is covered by a quality scheme as referred to in Regulation (EU) 2024/1143.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Annex IV Part A lists eight criteria, among them product protection, filling processes, logistics, hygiene and safety, and legal requirements. The justification goes in the technical documentation under Annex VII.
One sentence in there is worth reading twice. For each criterion, you have to identify the design requirements that prevent further reduction of the packaging weight or volume (Article 10(4)(b)Article 10(4)(b)for each of those performance criteria, the identification of the design requirements which prevent further reduction of the packaging weight or volume;PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.).
That is a document in which someone writes down why the box is the size it is.
Where the leaflet sits
Be precise here, because a lot of commentary this week will not be. PPWR regulates packaging. Annex I does not list an instruction leaflet as packaging. Nothing in this regulation tells you to remove one.
What it does is turn the volume inside your carton into a documented decision. And for many devices, the leaflet is what sets that volume. It is often the largest flat item in the pack. It is printed in a stack of languages. The carton is sized around the folded leaflet plus the device, not around the device alone.
Now look at how Annex IV frames information. Criterion 5Annex IV, Part A, Section 5Information requirements: the packaging design shall ensure that any necessary information regarding the packaged product itself, its use, storage and care, including safety instructions, can be provided to end users. Requirements may include providing product information, instructions for storage, application and use, bar codes and the best before date.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected. says the packaging design must ensure that necessary information about the product, its use, storage and care, including safety instructions, can be provided to end users.
The criterion is about the information reaching the user. It does not say the information has to be a folded sheet inside the box.
Since July 2025, for professional-use devices, it does not have to be. Commission Implementing Regulation (EU) 2025/1234 amended Regulation (EU) 2021/2226. Electronic instructions for use are now available for all devices intended for professional users, including accessories and the products listed in Annex XVIAnnex XVI1. Contact lenses or other items intended to be introduced into or onto the eye.2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR. The old rule reached only implantables, fixed installed devices and devices with a built-in display. Software had a separate route of its own.
So picture writing that Annex VII justification. You reach the space taken by the leaflet. For a professional-use device, the honest entry is not “legally required in the box”. It is “we chose paper”.
That may well still be the right choice. It is now a choice that has to be written down.
Two limits are worth stating plainly, because ignoring them turns a packaging project into a nonconformity. Where a device may foreseeably be used by a lay person, the instructions for that lay person stay on paper. And eIFU never removes paper completely. Any user who asks for a paper copy is entitled to one at no additional cost, at the latest within 7 calendar days of the request. What changes is that paper becomes a service you provide on request, not a print run you commission.
What to do in the next twelve months
February 2028 is eighteen months away. Packaging changes in this industry move at the speed of change control, validation and notified body review, not at the speed of a design decision.
One more date belongs on the list. The Commission was to ask the European standardisation organisations by 12 February 2027 to prepare harmonised standards for measuring minimisation (Article 10(3)Article 10(3)By 12 February 2027, the Commission shall request the European standardisation organisations to prepare or update, as appropriate, harmonised standards laying down the methodology for the calculation and measurement of compliance with the requirements concerning packaging minimisation under this Regulation. For most common packaging types and formats, such standards should specify maximum adequate weight and volume limits, and, where appropriate, wall thickness and maximum empty space.PPWR · Official Journal text of 2025-01-22. The authentic text as published. Any later amendment is not reflected.). Those standards should specify maximum weight and volume limits, and where appropriate wall thickness and maximum empty space. They are what you will eventually be held to.
Four things are worth doing now.
- Work out which of your devices are professional use only. Those are the ones where the leaflet is legally removable today.
- Model the carton without the folded leaflet. You need to know whether this is a marginal saving or a change of carton size.
- Check what EPR costs you per unit. That number turns a packaging question into a finance question.
- Start the eIFU documentation now rather than in 2027. The conditions attached to eIFU, including keeping every published version permanently available, are the slow part.
PPWR does not require you to move to eIFU. It changes what the paper leaflet costs you, and it puts a date on the day you will have to justify it.
Sources
Primary sources. Every claim in this post is traceable to one of these.
Show 3 sources · 13 references
- Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC, OJ L, 22.1.2025: https://eur-lex.europa.eu/eli/reg/2025/40/oj
- Article 71: entry into force and application from 12 August 2026.
- Article 5(4): 100 mg/kg limit on the sum of lead, cadmium, mercury and hexavalent chromium. Article 5(5): PFAS limits for food-contact packaging from 12 August 2026.
- Article 6(11)(b) and (c): recyclability requirements do not apply to contact-sensitive packaging of devices under Regulation (EU) 2017/745 or of IVDs under Regulation (EU) 2017/746. Article 6(12): review by 1 January 2035.
- Article 7(4)(b) and (c): recycled content requirements do not apply to contact-sensitive plastic packaging of those devices, including research-use and investigational devices.
- Article 10(1): minimisation by 1 January 2030. Article 10(2) and Annex IV: performance criteria. Article 10(3): harmonised standards requested by 12 February 2027. Article 10(4)(b) and Annex VII: technical documentation identifying the design requirements preventing further reduction.
- Article 12(1): harmonised labelling from 12 August 2028 or 24 months after the implementing acts, whichever is later. Article 12(11): conditional non-application to immediate and outer packaging under the MDR, IVDR and medicinal product legislation where there is no space.
- Article 24(1) to (4): the 50 % empty space ratio and its date formula, the methodology implementing acts due by 12 February 2028, the definitions of empty space, filling materials counted as empty space, and the sales packaging duty from 12 February 2028.
- Articles 38 and 39, Annex VII: conformity assessment against Articles 5 to 12 and the EU declaration of conformity.
- Articles 44 and 45: register of producers and extended producer responsibility.
- Article 2(1) and 2(2): scope covering all packaging, and the without-prejudice clause on safety, quality, health and hygiene requirements.
- Article 15(11): conformity assessment, technical documentation and the declaration of conformity do not apply to custom-made transport packaging for configurable medical devices and medical systems.
- Annex I, Section A: sterile barrier systems listed as packaging.
- Annex IV Part A, criterion 5: information requirements as a performance criterion.
- Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32025R1234
- European Commission, guidance document on the Packaging and Packaging Waste Regulation, approved 30 March 2026: https://environment.ec.europa.eu/publications/guidance-document-packaging-and-packaging-waste-regulation-ppwr_en
About this post
Ydntfy runs electronic instructions for use for medical device and IVD manufacturers, built to the conditions in Articles 4 to 7 of Regulation (EU) 2021/2226 for devices under the MDR and to Annex I, Section 20.1(f) of the IVDR for in vitro diagnostics. You can see how it works at ydntfy.com.
Originally published at https://ydntfy.com/en/blog/ppwr-applies-today-medical-device-packaging-leaflet/ on 12 August 2026. You are welcome to quote or reuse this, with a link back.