Does PPWR Apply to My Swiss Start-up or Scale-up?
Three Questions to Get Clear on Your Role Under the EU Packaging Regulation
The EU Packaging and Packaging Waste Regulation (PPWR) has applied since 12 August 2026. In the conversations I’ve had since, these two assumptions come up repeatedly: "Medical device packaging is exempt" and "We’re too small for this." Neither is true. So, does PPWR apply to my Swiss Start-up or Scale-up? Here are the three questions that determine your case and what actually applies if the answer is yes. By the end, you should be clear about your role and responsibilities, and able to explain them in your next team meeting.
Question 1: Does any of your packaging reach the EU market? The PPWR covers all packaging and all packaging waste, whatever the material; from industry, retail, offices or households. There is no carve-out for the MedTech sector as such, and none for device class either. A Class I dressing and a Class III implant are treated exactly the same. If you have a pure software product, or nothing you sell reaches the EU, you can stop reading now. Being established outside the Union is not a carve-out: the Regulation applies for packaging placed on the EU market, independent of where your office is.
Question 2: Is it placed on the market under your name or trademark?
Then you are the manufacturer of that packaging, and you carry most of the obligations you must draw up the technical documentation, carry out a conformity assessment and issue an EU declaration of conformity, and keep both for five years - or ten years if the packaging is reusable.
This is the part most teams underestimate. Whether you are the founder or the person who has quietly inherited regulatory alongside everything else.
And one important point: this is not the same technical documentation and DoC as for the device. The packaging requires its own separate set.
It is a self-assessment, so there is no notified body involved, which is good news for your timeline. But the documentation still needs to be prepared and must be provided to the competent authorities on request.
If you have a contract manufacturer producing packaging to your specification and it is placed on the market under your name or trademark, you are the manufacturer. The contract manufacturer is your supplier, with a legal duty to provide you with the information and documentation you need to prove conformity.
Question 3: Who first makes it available in each Member State?
That party is the producer, and the producer carries the extended producer responsibility obligations: register in the national producer register, pay the applicable EPR fees and report annually. And this applies separately in each Member State.
Who takes on this role depends on your sales channel, not on who manufactured the packaging:
Sell through an EU importer or distributor, and the producer role sits with them.
Sell direct to end users such as hospitals, clinics or labs, and the producer role stays with you, even if you are established in Switzerland. In that case, you will also need an EPR representative in each Member State where you sell directly.
And one important distinction: your EPR representative is not the same as your MDR EU Representative.
"But we’re a start-up"
There is no general Start-up, Scale-up or SME exemption under the PPWR. Three mechanisms do vary according to the company size, but only two of them are useful if you are based in Switzerland:
Below 10 tonnes of packaging made available per Member State per calendar year, a reduced set of reporting requirements applies. This is relevant for most start-ups and scale-ups, and there is no establishment condition attached.
Micro-enterprises below 1000 kg of packaging per Member State per year are exempt from the re-use targets that apply from 2030. Again, there is no establishment condition, so this exemption is also relevant for Swiss companies.
Micro-enterprises with fewer than 10 employees and annual turnover or an annual balance sheet total below EUR 2 million can pass certain manufacturer obligations to their supplier. But this only works where that supplier is established in the same Member State as the micro-enterprise. The Commission applies the same principle to the EPR obligations. For a company established in Switzerland, that condition can never be met, so unless you have an EU entity, treat this exemption as unavailable.
One important caveat on the micro-enterprise threshold: if an investor or parent company holds 25% or more of your capital or voting rights, you will need to include their headcount and financial figures into yours - proportionally above 25%, in full above 50%.
What actually applies, and from when
When | Who it applies to | What is required |
Since 12 Aug 2026 | Manufacturer | Lead, cadmium, mercury and hexavalent chromium (“heavy metals” together at or below 100 mg/kg across every component. Substances of concern minimised. Technical documentation, conformity assessment and EU declaration of conformity. Type, batch or serial number plus your name and address on the packaging (+ importer). |
Since 12 Aug 2026 | Producer | Registration in the national producer register of each Member State, EPR fees and annual reporting. You may not make packaging available in a Member State before you are registered there. The harmonised EU register format is still pending, so today this runs through the existing national schemes - the first report under the new rules is due by 1 June 2030. |
12 Feb 2028 | Sales Packaging (Manufacturer) | Empty space reduced to the minimum needed for the packaging to function. Filling material such as air cushions, foam, paper counts as empty space. |
12 Aug 2028 * | Manufacturer | Harmonised material label. It does not apply to transport packaging at all unless you ship e-commerce, and it is not applicable to immediate and outer packaging where other EU labelling requirements leave no room. |
1 Jan 2030 * | Manufacturer | Design-for-recycling performance grades and minimum recycled content in plastic packaging. |
1 Jan 2030 * | Whoever packs | Empty space capped at 50% for grouped, transport and e-commerce packaging. |
1 Jan 2030 * | Whoever ships | 40% re-use target for transport packaging. Cardboard boxes and packaging custom designed for large-scale equipment are excluded. |
* Note: These dates can change. The Regulation ties them to delegated and implementing acts that the Commission has not yet adopted, and each reads "the stated date, or a period after those acts enter into force, whichever is the latest". Plan for them, do not treat them as fixed. Only the 12 February 2028 empty-space date carries no such condition.
So, what should do now?
Some of this is not future work. If the PPWR applies to you, the requirements for packaging technical documentation, the EU Declaration of Conformity and producer registration have been due since 12 August 2026.
And registration is a condition for placing packaging on the market, not simply an administrative filing: you may not make packaging available in a Member State before you are registered there.
Work in this order - each step decides the next:
1. Fix the roles. For every packaging unit, establish who is the manufacturer and who is the producer in each Member State. Write the answers down. Everything else follows from these two.
2. Ask your suppliers early. Request the conformity information for each component, and, if necessary, point suppliers to their obligation to provide it. I know that, particularly for start-ups, getting this information can sometimes be difficult.
In my experience, this is most often the longest lead-time in the whole process, so start early.
3. Build the file, then assess. Prepare the technical documentation first, then carry out the conformity assessment and draw up the EU Declaration of Conformity (DoC).
And remember: this is not the technical documentation and DoC for your medical device. Your packaging requires its own documentation.
Where this usually goes wrong
First: the roles. In my experience, this is where companies lose the most time. Not because the rules themselves are particularly difficult, but because the terminology is different from the MDR and nobody owns the question; until an importer asks for a packaging Declaration of Conformity.
Second: supplier timing. Component data tends to be requested only once someone has already started writing the technical documentation. In the worst case, that can add weeks nobody planned for.
Third: the technical documentation and Declaration of Conformity themselves. Teams assume that the documentation they already hold for the device also covers the packaging. As a result, nothing gets prepared until someone in the supply chain asks for a document that does not exist.
If you would like a sounding board for your PPWR assessment (roles, technical documentation or DoC), book a 20-minute discovery call.
We will establish whether you need a single session or something more involved, and I will tell you honestly which it is. Any follow-on work is one-to-one, charged per hour and designed so that you leave knowing exactly which steps to take next.
If you would rather learn more first, I covered all of this in more depth in a recent webinar for Swiss MedTech companies hosted by Swiss Medtech, including the Swiss Packaging Ordinance. You can watch the recording here.
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Regulatory Affairs and Circular Economy - explained in plain English.
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