Erik Vollebregt wants to show you where MDR and IVDR are headed in 2026 and beyond

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Erik Vollebregt, partner at Axon Lawyers.

Can you briefly describe your current role? 

My current role is twofold. My day job is being one of the founding partners of Axon Lawyers, a top tier life sciences boutique law firm in Europe. We advise and litigate across the full scope of life sciences: pharmaceuticals, biotech, medical devices, and food. That's my day job. As my side job, I co-founded a regulatory AI company, Raiana, and it's been very interesting so far.  

You’ve been a lawyer for 27 years in life sciences. What role do MDR and IVDR play in your day-to-day now? 

I advise individual companies, member states, European institutions, and industry associations on these regulations, related regulation and their impacts. I’ve been working on all sides of the discussion of the current revision of the legislation. 

For my day-to-day, I wouldn't say it's 90% MDR and IVDR only, but rather it's 90% medical devices industry and related regulation. That's also because I'm the partner responsible for the devices industry area in our firm. I think it would be weird if that weren’t the case. For medical devices and diagnostics, that also includes all related aspects like software, data protection, AI, batteries regulation, packaging, chemicals and waste regulation. The whole regulatory lasagna, if you will, is on the menu there. And my group does a lot of M&A, commercial contracting and IP licensing work in the devices and diagnostics space.  

As for the remaining 10%, while people know me very well for my medical device and diagnostics expertise, I also increasingly do interesting work in the pharmaceutical and chemicals fields as well. For example, I have several cases pending at the European Court of Justice and at the EU General Court about combination medicines and biocides.

You are one of the speakers on the panel for MDR/IVDR State of Play at RAPS Convergence. How did this session come to be? 

This session has the usual suspects for the inside track on what's happening in Europe medical devices-wise. This one is going to be very interesting because Europe has embarked on a more fundamental revision of devices regulation than people might realize. What we are going to do in the session is give people a look at where things are actually going. We’ll cover how the political mechanics of the logistic procedure works, where we expect things to land, what people should prepare for. 

Separately, this same panel is hosting a two-day preconference workshop where we will explain the whole proposal so you can know exactly what is going to change and why, what to expect as outcomes and what to prepare for. I really recommend attending this workshop to get a strategic picture that will inform the company’s short and mid-term European strategy. I personally think that this workshop will be one of the best opportunities in the US this year to be updated on the revision of EU devices regulation with this level of detail and expertise. 

The one-hour session is more strategic and conceptual, whereas the two-day workshop very much deals with the substance and detail. For example, we are thinking about a new breakthrough device procedure. What will it look like? How does it compare to the US breakthrough device procedure? We're going to have a new orphan procedure. What will it look like? How does it compare to other orphan procedures? We’ll get in-depth on all that. It’ll be fun and very useful. The idea is to give attendees a deep understanding of the changes and an early strategic edge.

You’re also speaking at Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation. What excites you about that session? 

This is a session that has been very well-visited the last couple of times, but we’re doing it a bit differently this year. 

I'm pairing up with Gregory Lamantia from Intuitive Surgical. We’ll go through a scenario where you are a manufacturer, and you have the same device that you're going to market both in the US and the EU, maybe even worldwide. What do you run into in terms of environmental regulation in different places? And how can you actually make a good plan to navigate all these different laws? Because usually on the substance, these laws all want the same thing. But the formalities and approaches can be wildly different. We’ll show you how to navigate that, and how to make this actionable within the company. I think that's an interesting new angle to this presentation. And I’ll still be available to answer any EU regulation-related questions, of course.

What do you get out of RAPS Convergence as an attendee?

It's the top opportunity of the year to be over in North America and actually speak to a lot of my client contacts, because quite a large portion of my practice is for US-headquartered clients. RAPS Convergence is a really nice way to be in personal contact with people you normally only see through Zoom and Teams. Personal contact, for me, is still one of the nicest ways to meet people. The conference is ideal for networking, and I think you get a lot of new ideas by meeting people that you weren’t planning to meet. There's a good amount of serendipity in this conference, which I always really like. 

What is one thing you are looking forward to at this year’s event?

Meeting people in person. I typically engage in a lot of discussions on LinkedIn, but it's so much nicer to have these conversations in person. What I also always like is when after a session, you have people who approach you with genuinely interesting questions about things that you haven't thought about. You can help them get unstuck and see new angles to issues that you had not thought about yourself yet. That human factor is what I'm really looking forward to. I would encourage people to get out of their usual bubbles and speak with new people and for people to not hold back and ask me anything. Or talk about windsurfing and scuba diving, that’s great too.