Why the 9R System Matters - Even If You’re a Founder Buried in MDR

In my previous post I explained what circular economy is and introduced the 9R system. Now let’s look at why it matters to you as a MedTech founder.

If you’re deep in MDR submissions and audit prep, “I don’t have time for one more thing” is a perfectly reasonable reaction. But circularity isn’t just another item on your regulatory to-do list. It can help you reduce costs, make your business more attractive to investors and partners and strengthen your product for the long term.

In fact, you may already be applying some circular economy principles without even calling them that.

Reasons Circularity Is Worth Your Limited Time

New regulations are on the way

Several new EU regulations are either already in force or coming into effect over the next few years, and they will have implications for medical devices.

The EU is making a significant push towards a more circular economy, with a particular focus on keeping critical raw materials in circulation and reducing (packaging) waste.

The battery law [4] introduces new requirements from February 2027 (see my previous post on this topic). The packaging regulation [5] applies as of August 2026, with key requirements directly affecting your packaging design coming into force from 2030. And the new Ecodesign regulation [6] is another piece of legislation worth keeping on your radar.

If you haven’t come across these regulations yet, don’t worry. I will be covering each of them in future blog posts.

Material choice makes you an attractive partner for large MedTech players.

Switzerland has committed in law to achieving net-zero GHG emissions by 2050 [7]. The Swiss MedTech industry has developed its own decarbonisation roadmap, and many large MedTech corporates have set ambitious net-zero targets of their own. Improving circularity is one of the key ways to achieve them.

This presents an opportunity for start-ups.

If you’ve already made deliberate, circular-ready material choices, your company may be a more attractive licensing, supply or acquisition partner than one that hasn’t.

Why? Because if an acquiring company needs to change your materials after the acquisition to meet its own sustainability targets, that modification would likely be a significant change under MDR - meaning re-assessment by the Notified Body, adding considerable time, cost and regulatory complexity to the integration.

Less packaging, less material, lower cost. 

Most founders only care about the product, and I get it. But there is value in looking at the packaging too.

Smaller packaging and choosing more sustainable materials can reduce your environmental footprint while also lowering your cost of goods. I’ve spoken to packaging engineers at global players who achieved cost savings of up to 30% through packaging redesign projects. As a start-up, you have the advantage of getting it right from the start!

For a seed-stage company watching runway, that is real money today, regardless of any sustainability objectives.

Last but not least, new business models can reduce GHG — and buyers notice. 

Service and rental models (R1, R3) allow a single device to serve multiple patients or healthcare providers rather than each hospital purchasing and under-utilising its own equipment.  In simple terms, fewer devices need to be manufactured, transported and ultimately disposed of for the same healthcare outcome.

The benefits don’t stop with your own emissions. A hospital using your service model instead of purchasing multiple units may be able to showcase a lower supply-chain footprint in its own ESG reporting. Likewise, investors with climate commitments are increasingly looking for businesses that can demonstrate measurable emissions reductions across the value chain.

That makes circularity a commercial opportunity as much as an environmental one. Hospitals with net-zero commitments increasingly factor supplier emissions into procurement decisions.

That’s the business case.

In my next post, I’ll explore where the real opportunities for MedTech start-ups lie, looking at each of the 9R strategies in turn.

If any of this resonates with you but you’re not sure where to start, drop a comment or send me a message; I’d be happy to think it through with you.

References:

[4] European Parliament and Council of the European Union. Regulation (EU) 2023/1542 concerning batteries and waste batteries, 12 July 2023. Official Journal of the European Union, L 2023/1542. https://eur-lex.europa.eu/eli/reg/2023/1542/oj/eng.

[5] European Parliament and Council of the European Union. Regulation (EU) 2025/40 on packaging and packaging waste, 19 December 2024. Official Journal of the European Union, L 2025/40. https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng.

[6] European Parliament and Council of the European Union. Regulation (EU) 2024/1781 establishing a framework for the setting of ecodesign requirements for sustainable products, 13 June 2024. Official Journal of the European Union, L 2024/1781. https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng.

[7] Federal Council of Switzerland / Federal Office for the Environment (FOEN). Switzerland’s Long-Term Climate Strategy (net-zero GHG emissions by 2050), adopted 27 January 2021, updated January 2025. https://www.bafu.admin.ch/en/climate-strategy-2050.

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Regulatory Affairs and Circular Economy - explained in plain English.

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