PPWR and Medical Devices: The Regulation Most Device Companies Haven't Scheduled Yet

On August 12, 2026, the EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), or PPWR for short, will come into full effect. Most medical device companies I've spoken with have quietly decided this regulation doesn't apply to them, as it sounds like something related to cereal boxes and plastic bags in supermarkets. This mistake could prove costly. There is no blanket exemption for medical devices from PPWR, and for a large part of your packaging, it applies just as it does to any other consumer product.

What is this Regulation Anyway?

PPWR is a European regulation designed to reduce the amount of packaging waste in Europe. It did not originate from the medical device world at all.

Its background is consumer-oriented – every European citizen generates an average of about 186.5 kg of packaging waste per year, and this amount is growing faster than the population. The European Union decided to address this with a single law that applies to all packaging placed on the European market, regardless of the industry and the material it is made from.

The regulation officially entered into force on February 11, 2025, and replaces an older directive from 1994. It has one general application date, August 12, 2026, and beyond that, a series of additional deadlines extending until 2040 (recyclability targets, increased use of recycled material, performance-based extended producer responsibility systems).

The stated goal is that by 2030, all packaging marketed in Europe will be economically recyclable, and the amount of recycled material in it will gradually increase.

The Important Difference Between PPWR and MDR

The MDR was written specifically for medical devices. It recognizes the term medical device and is built around it. The PPWR is a horizontal law, meaning it applies to every industry at once and was not written with medical devices in mind at all. It simply asks one question: Is this packaging placed on the European market? If so, the law applies. The sector in which the product is located is irrelevant, unless the legislator bothered to include a specific exception for that sector. And this is exactly what happened in the case of medical devices, but the exceptions are much narrower than most people think.

There's something else to know before diving into the details – the PPWR is structured with articles and annexes, just like the MDR, and it uses terms that sound very familiar: manufacturer, importer, authorised representative, declaration of conformity, technical documentation. The natural temptation is to assume these are the same concepts we already know, just in a different context. This is a mistake. Each of these terms has an independent and separate definition within the PPWR, which does not necessarily overlap with the corresponding definition in the MDR. We will return to this in detail later.

How is this related to your medical device?

Every medical device marketed in Europe is wrapped in packaging, usually in several layers:

Primary packaging is what directly touches the device. For a sterile device, this is usually a pouch with a sterile barrier, such as Tyvek or polyethylene.
Secondary packaging is the carton that packs the individual unit, with the labels, instructions for use (IFU), and CE marking.
Transport packaging is the larger carton that ships several units together to a distributor, hospital, or warehouse.

The PPWR does not ask whether it is a medical device. It sees three layers of packaging, and from its perspective, all three must meet the requirements:

To be recyclable
Not to contain unnecessary void space
Not to exceed heavy metal limits
And to be registered in an Extended Producer Responsibility (EPR) system that charges a fee based on the amount of packaging and its recyclability level.

Where does the confusion about "exemption" come from?

There is a genuine exception, but it is very focused. The legislator understood that it is not possible to demand that a sterile pouch enclosing a medical device switch to a "more recyclable" material if the change could compromise the sterile barrier. Therefore, a specific exception was written in Article 6 of the regulation: contact-sensitive packaging of a medical device or in vitro diagnostic device is exempt from the mandatory recyclability requirement, if a change in its material or structure could impair the safety of the product or its sterility.

This applies only to the innermost layer, the one that directly touches the device.

It does not apply to the carton around it.

It certainly does not apply to transport packaging.

These must fully comply with the recyclability requirements, just like any other packaging on the market.

And even the inner pouch, although exempt from the recyclability requirement, is not exempt from the rest of the law. It must still comply with the heavy metals limit, still falls within the EPR calculation, and still requires technical documentation and a declaration of conformity from the packaging manufacturer. So when someone says "there's an exemption for medical devices," they usually mean this narrow exception, and don't necessarily understand how limited it actually is.

There are two more, smaller, concessions worth knowing about:

Customized transport packaging (Article 15) for complex and customized medical equipment, such as large imaging systems or industrial-medical equipment, is not subject to the full cross-cutting conformity assessment procedure and the obligation to maintain extended technical documentation for a period of 5 to 10 years. You will still need to make documentation available to supervisory authorities within 10 days if requested.
Marking and labeling If a change in the packaging marking could compromise compliance with MDR requirements, there is flexibility in applying the cross-cutting PPWR marking rules to the packaging.

Recycled content (Article 7) This is a completely separate requirement from the recyclability requirement of Article 6, and it's important not to confuse them.

Article 6 addresses the question: Can the packaging be recycled at the end of its life?

Article 7 addresses the question: How much recycled material is already in it from the outset?

Both articles set different targets, with different timelines, and with different legal logic.

According to Article 7, from 2030, plastic packaging must contain a minimum percentage of recycled material sourced from post-consumer waste, not production waste. The percentages vary depending on the type of plastic and packaging, and increase again in 2040. Various sources describe "contact-sensitive" packaging differently under this article, some including food packaging and medical device packaging in this category, while other sources speak of a specific and direct exemption for medical device and in vitro diagnostic packaging. The practical conclusion: there is some relief here for medical devices under Article 7, in a similar spirit to the exception in Article 6, but the exact details (on which packaging layers it applies, and under what conditions) require verification against the full text of the regulation and the guidance document published by the Commission in March 2026, and it is not advisable to rely on secondary summaries on this point alone.

Medical devices don't get all the benefits, but there's another point of relief worth knowing about.

Beyond the packaging exceptions themselves, there's another area where the regulation considers the medical context: single-use packaging bans.

From 2030, the PPWR bans a series of single-use packaging formats deemed unnecessary, primarily in the food and hospitality sectors, such as small sachets of sauces and condiments in restaurants, or tiny shampoo bottles in hotels (Annex V, Article 25). These bans do not apply when single-use packaging is necessary for safety, hygiene, or medical requirements, for example in hospitals, clinics, and care facilities. This is not a concession related to the device packaging itself, but a recognition that in a clinical environment, single-use packaging is sometimes precisely what is required for safety and infection prevention, and not "waste" that needs to be reduced.

Familiar roles, but not the same

This is where experienced regulatory professionals fall the most, precisely because they are experienced. PPWR defines in Article 3 of the regulation an entire group of "economic operators": manufacturer, producer, importer, distributor, authorised representative, and fulfillment service provider. The names are identical to what is known from the MDR. Their legal definitions are completely separate, and do not automatically inherit from each other.

The manufacturer under PPWR is not necessarily the legal manufacturer of the device. Under PPWR, the manufacturer is defined by who manufactures the packaging itself, or orders its manufacture under their brand (Article 3(13)). This may be the same company that is the legal manufacturer of the device under the MDR, but this is not guaranteed. For example, if a European distributor re-packages a product in a target country, they may be considered the manufacturer under PPWR for that packaging, even if they are defined as a distributor only under the MDR.
An Authorized Representative under PPWR is a different role from the EU Authorized Representative known from the MDR. The AR under PPWR is explicitly appointed to handle registration and reporting to the EPR system in a specific country, when the company does not have a physical presence there. This is a role with a narrow mandate, and does not necessarily fall on the same entity that fulfills the role of the EU Rep under Article 11 of the MDR. You can certainly find yourselves with two different entities, for two different laws, for the same product.
The Declaration of Conformity under PPWR is a completely separate document from the EU Declaration of Conformity you already have for the device. The Declaration of Conformity under Annex VIII of PPWR applies only to the packaging, and does not merge with the Declaration of Conformity of the device itself. Two separate documents, two separate procedures, and separate legal liability for each one.

The practical implication is that you cannot take your existing mapping of economic operators, already built according to the MDR, and assume it is also valid for PPWR. You need to perform this exercise again, specifically for each type of packaging and each target country, because PPWR determines roles according to who actually handles the packaging in a given supply chain, and not according to the role the company already holds under another regulation.

What has actually changed for you?

Heavy metal limits. The obligation to comply with the general limit of 100 mg/kg for heavy metals (lead, cadmium, mercury, hexavalent chromium) applies in full, including to medical device packaging. This is not a fundamentally new problem in most cases, but it requires formal testing and documentation that many companies have not yet performed.
PFAS. The restriction on PFAS (Per- and polyfluoroalkyl substances), what are called "forever chemicals," applies only to packaging that comes into contact with food. This restriction is generally not relevant to medical device packaging, unless it also comes into contact with food, for example, in feeding equipment. It's worth checking this specifically and not assuming it's irrelevant.
Packaging minimization. From 2030, the void space ratio in transport packaging, e-commerce packaging, and grouped packaging must be up to 50%. Structures such as hollow double walls, artificial thickening, or double bottoms designed solely to increase packaging volume are prohibited. This directly relates to a common pattern in the medical device industry: a large box, a small product, generous padding. If your packaging is constructed this way for reasons of protecting sterility or a fragile product, that's fine, but you'll need to be able to justify it in documentation, not just rely on "this is how we've always done it."
EPR, Extended Producer Responsibility. Here, there is no relief for medical devices. Companies that market packaging in Europe must register with the EPR (Extended Producer Responsibility) system in every member state in which they operate, and report how much packaging, by weight and material type, they place on the market. This report is submitted to the responsible body in the country, the PRO (Producer Responsibility Organisation), which funds the actual collection and recycling of waste. If the company does not have a physical presence in that country, an authorized representative must be appointed for this purpose only, and not necessarily the same entity that fulfills the role of the EU Rep under the MDR. Based on this report, the company pays a handling fee. This payment is not uniform: the PPWR requires a tiered tariff according to the degree of recyclability of the packaging, a mechanism called eco-modulation. The less recyclable the packaging, the more is paid per kg. This is effectively a built-in economic penalty for "bad" packaging from an environmental perspective, and an economic incentive for "good" packaging. Member states are already implementing EPR schemes with this tiered pricing, and by 2030 the link between the payment amount and the recyclability level is expected to be even more binding in all countries.
It is important to distinguish between two separate "files" created here, as it is easy to confuse them. One is the technical file (Annex VII, detailed below): it proves that the packaging complies with design requirements, such as deviation from heavy metal limits and recyclability. The other is EPR documentation: active registration in every relevant country, periodic reporting of quantities placed on the market, and documentation that supports the declared recyclability classification, so that it is possible to justify why certain packaging was classified at a certain level and not just pay and hope for the best. Even if your internal packaging is exempt from the recyclability requirement itself thanks to the exception in Article 6, it is not exempt from registration, reporting, and not necessarily from the payment itself.
Declaration of Conformity and Technical Documentation. Article 38 of the regulation establishes a conformity assessment procedure that a packaging manufacturer, including a company that orders the manufacture of packaging under its brand, must undergo before the packaging is placed on the market. This is followed by technical documentation according to Annex VII, and finally a signed Declaration of Conformity according to Article 39 and Annex VIII.
There is a relatively reassuring message here: the conformity assessment procedure under PPWR is Module A, internal production control. This means that the manufacturer performs the assessment itself, without a notified body and without external approval, and usually without any payment or institutional approval process. In other words, this is not a process similar to the intervention of a notified body that we know from the world of the MDR. The manufacturer prepares the file, signs the declaration, and assumes full legal responsibility if any authority inspects and finds that the file does not support the declaration.
The technical file according to Annex VII includes, among other things: a general description of the packaging, component-level construction drawings, material specifications for each layer and each component, test results for Substances of Concern (as defined in the regulation, substances with potential negative impact on health or the environment, or that impair the quality of recycled material), including PFAS, data on compliance with heavy metal limits, and recyclability and minimization assessment. This file must be prepared before the packaging is marketed. The retention period is not uniform: single-use packaging requires document retention for a minimum of 5 years, and reusable packaging requires retention for a minimum of 10 years. This is a completely separate layer of documentation from the technical file of the device itself under the MDR, and does not automatically overlap with it, even if some of the data (such as material specifications) already exist elsewhere.
Regarding small companies: There is no general exemption. It is worth stating this explicitly, as this is a common misconception among startups. The PPWR does not include a blanket exemption for micro or small companies from its central obligations, such as Declaration of Conformity, technical documentation, and registration. There is one narrow point that is relevant: in the definition of "producer" for EPR obligations, a company that orders the manufacture of packaging under its brand and is defined as a micro-enterprise (less than 10 employees and turnover below 2 million euros) is not automatically considered a "producer" for this reason alone. This is a very specific concession in the definition, not a general exemption from the regulation, and it should be checked specifically and not assumed to apply to every aspect of the activity.

What happens if you don't comply with regulatory requirements?

The regulation itself does not set uniform penalty amounts. Article 68 obliges each member state to establish its enforcement and sanction mechanism, and requires that states do so by February 12, 2027, about six months after the general application date. The regulation requires that sanctions be "effective, proportionate, and dissuasive," but the actual amounts are determined at the national level, and therefore will vary from country to country. For violations of certain articles (24-29, which mainly deal with reusable and refillable packaging requirements), the regulation does require that states specifically include administrative fines.

Beyond fines, there is also a more direct sanction: according to Article 39(5), packaging that does not comply with the requirements, or whose declaration is not supported by a valid technical file, can be removed from the market by order of the supervisory authority, regardless of any financial penalty. In other words, even if the fine in a particular country turns out to be relatively low, the real exposure is not just financial – it's a real possibility that your product, because of its packaging, will be temporarily or permanently removed from the shelf in Europe until the documentation is corrected.

Why August 12, 2026, is a date to mark on your calendar

This is the date from which most of the obligations in the regulation enter into enforceable effect. There are other deadlines extending until 2040, but August 2026 is the starting point from which authorities can already request documentation and check actual compliance.

How this connects to what you already have

If you have a quality system according to ISO 13485, you already have a foundation to build upon. The packaging validation process according to MDR requirements, which ensures that the packaging maintains sterility and information integrity, is not identical to PPWR requirements, but it partially overlaps with them in terms of the required documentation and testing. The first practical step is to map all your primary, secondary, and tertiary packaging, and for each one, indicate whether it is contact-sensitive in the sense that Article 6 refers to, or regular packaging that does not benefit from any relief.

This is not a problem that can be solved in a day, nor is it a problem that can only be solved by the regulatory team. It touches on purchasing, product development, and packaging itself as a professional field, and most small and medium-sized medical device companies don't even have a dedicated person responsible for it. If you market to Europe, it's worth starting to ask now who in your company is even responsible for checking this, before the next audit or some inquiry from a local authority does it for you.