The EU is promising to speed up the approval of medical devices. For innovative companies, this could mean less waiting and greater certainty. Or perhaps not. “When you start the certification process now, you don’t know what to expect. It can take two years or even more. That is killing the market opportunities,” says Przemek Grzywa from Revolve Healthcare.
The European Commission moved to address those concerns by revising its medical device framework and introducing structured deadlines for conformity assessments. But while the reform brings procedural clarity, questions remain over whether it delivers genuine predictability, particularly for complex applications that may still face capacity bottlenecks or procedural restart risks.
EU Perspectives spoke with Przemek Grzywa, co-founder of Polish medical software company Revolve Healthcare, about whether the changes will ease the pressure on small and medium-sized innovators navigating Europe’s certification system.
What has been the biggest challenge under the MDR regulation in practice?
To be frank, the bottleneck is with Notified Bodies. Under MDR, medium- and high-risk devices must be assessed by designated third-party bodies, known as Notified Bodies, before entering the EU market.
If you compare it with the US, the FDA has a deadline for when they have to go back to you with feedback. We should have something similar, because that gives companies predictable timelines.
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When you start the certification process now, you don’t know what to expect. It can take 12 months, 18 months, 24 months, or even more. That is killing the opportunities on the market.
There are some Notified Bodies that can do certification in six months. That should be the standard. Six to twelve months maximum should be the standard.
The European Commission is proposing structured deadlines. Will that solve the issue?
We finally get specific timeframes for individual stages of the assessment carried out by the Notified Body. That is a positive step.
But even if we have timelines included, the number of auditors is still the same. We either have to increase the capacity of the Notified Bodies, or take some things out of the process.
Any solution that would allow innovative products to test clinically earlier, in a safe environment but maybe with a little bit less rigid way, for example with a small group of patients, would be very helpful.
Another issue is how those timelines are designed. Introducing a maximum number of “rounds” back to the manufacturer, during which the clock stops and the manufacturer can correct documentation, comes with a potential trap.
What if, after using all available attempts, further corrections are still needed? This is not a rare scenario, especially for more complex devices.
If that happens, the Notified Body may have to terminate the assessment. The manufacturer would then face the prospect of starting the conformity assessment procedure from scratch.
So I’m not sure if the presented changes will actually shorten the whole process. The bottleneck may be somewhere different.
What experience do you have with policy discussions around medical devices?
I participated in a task force put together by MedTech Europe. I was invited as an SME representative to take part in discussions around proposals for the Commission regarding upcoming changes to the regulation.
It was an interesting experience in terms of dynamics and real needs across different countries. Regulatory sandboxes were one of the ideas proposed as improvements.
Why do you see regulatory sandboxes as important?
Anything that allows MedTech companies to test, experiment or go through some iterations of the product quicker is a good way forward.
If you start building digital health solutions that will be a medical product, from day one to market launch it takes a minimum two or three years. It’s a long time and a lot of cost.
On average Europeans are healthier than Americans. That suggests we have a very robust healthcare system in Europe. We should focus on practical improvements, like predictable timelines, rather than just looking at the US.
Usually, you have to have a full product ready for certification before you can enter clinical trials. It can take 12 to 18 months to build the product, and then clinical trials can take 9, 12 or 18 months or more.
Any solution that would allow innovative products to test clinically earlier, in a safe environment but maybe with a little bit less rigid way, for example with a small group of patients, would be very helpful.
However, from an entrepreneurial perspective, whatever the European Commission proposes is still quite far away from the market. It will take months or years before it becomes available as an opportunity. That’s why companies are not looking into the specifics very deeply at this stage.
The proposal also suggests easier use of clinical data from equivalent devices. Is that helpful?
In general, it’s a good solution. However, if you think about very innovative products, and most medical startups are working on new products, new innovations, then it doesn’t help them, because there is nothing comparable.
Even if there is something comparable, it is usually very protected, because it’s an innovation.
In my opinion, this might be helpful for big companies that already have similar products on the market. But I don’t think it’s going to be the improvement when you think about innovative digital or non-digital MedTech solutions.
Some argue that stricter EU regulation pushes companies towards the US. Do you see that happening?
Making the comparison and saying that Europe is losing to the US is a very attractive narrative, but I don’t believe this is actually happening.
If the US is on your radar as a company from Europe, then you will go there anyway. If it’s not on your radar and you don’t have the capacity to go to the US, you won’t go just because it’s easier from the regulatory point of view.
There are a lot of other costs. It’s a completely new market. You need infrastructure, a sales force. In many cases, the FDA will not approve EU clinical trials, so you may have to repeat them.
I’m not 100 per cent sure that even if you have a more relaxed regulatory framework in the US, that this translates into better healthcare.
If you look at the comparison between Europe and the US, on average Europeans are healthier than Americans. That suggests we have a very robust healthcare system in Europe.
We should focus on practical improvements, like predictable timelines, rather than just looking at the US.
What advice would you give MedTech founders today?
Don’t wait for those changes to come. It will take time.
Specifically for startups, look for ways that you can do things quicker. There are strategies.
If possible, start with a Class I product. Medical devices in the EU are divided into risk classes. Class I represents the lowest risk and allows for self-certification, while higher classes require assessment by a Notified Body. It doesn’t require external certification.
Then you can be reasonably quick to the market. You can test it, sell it, talk to clinicians and patients, and at the same time work on Class II or higher.
The line between a wellness application and a medical device is very thin. If you build something for several months and then realise it is a medical device, it is very difficult to reverse engineer compliance. In the worst case scenario, you have to do it again.
If you think about the different classes of medical devices, it comes down to the risk for patients. With a very low risk, it’s the lowest class, Class I.
If you have a digital tool that is diagnosing a disease, helping to treat it or monitor a patient, then it will probably be in a higher class, Class II. If you have digital tools that pose a real risk, even a risk of death, then it’s Class III.
For example, software that runs a respiratory machine would be Class III, because if anything goes wrong, it can kill the patient.
The biggest mistake we see is lack of knowledge among MedTech startups. Many startups are building medical devices and they don’t know it.
It’s not that you decide whether it’s a medical product. If the software is helping to monitor, diagnose, alleviate, treat or prevent disease, then it is a medical device.
The line between a wellness application and a medical device is very thin. A step counter is not a medical tool if you use it for general physical activity. But if it becomes part of treating patients with diabetes, then it becomes a medical device.
If you build something for six, nine or twelve months and then realise it is a medical device, it is very difficult to reverse engineer compliance. In the worst case scenario, you have to do it again.
So if you even suspect that you are building a medical device, it’s very important from the early stage to talk to experts.
In one sentence, will simplification change the system?
It’s very good that the Commission started to talk about it and try to find solutions. But whether that actually changes something in practice, we will see.
Can you briefly introduce yourself and your company?
I’m one of the founders of Revolve Healthcare. I co-founded the company ten years ago and have been leading it ever since.
We are a medical software development company and act as a critical supplier for companies that design, build and certify medical software. Essentially, any product classified as Software as a Medical Device (SaMD) under the Medical Devices Regulation.
The company does not develop products of its own. Instead, it operates as a service-based partner, working with MedTech companies to build medical software and support them through the certification process.
We are certified under ISO 13485, the quality management system standard for MedTech companies. Our customers go through CE certification, and we support them throughout that process.
We currently have more than 50 employees and we work with companies across the European Union, including the UK and Switzerland. We are based in Katowice, Poland, although most of our projects are outside Poland.
