PPWR applies today: what it asks of medical device packaging

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 71).

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) says the regulation applies to all packaging, regardless of the material used. There is no sectoral exclusion anywhere in the text. And Annex I, 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) 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)). PFAS limits also start today, but they cover food-contact packaging only, so they do not reach device packaging (Article 5(5)). Conformity assessment against Articles 5 to 12 follows Annex VII, with an EU declaration of conformity (Articles 38 and 39). Producer registration and extended producer responsibility apply with no carve-out for medical devices (Articles 44 and 45).

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)). 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)). 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)). Grouped, transport and e-commerce packaging gets a cap of 50 % empty space (Article 24(1)). 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) and (4)).

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)) and, if it is plastic, the recycled content requirements (Article 7(4)). 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 10), 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)).

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)). 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.

1. Recyclability does not apply to the sterile barrier and other contact-sensitive device packaging (Article 6(11)).
2. Recycled content does not apply to that same packaging where it is plastic (Article 7(4)).
3. 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)).
4. Labelling does not apply to immediate and outer packaging where other labelling requirements have left no room (Article 12(11)).
5. 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 IV may not be placed on the market (Article 10(2)). 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)).

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 5 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 XVI 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)). 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.