How to unleash the power of Europe’s health industries

The medtech industry is an innovation powerhouse. However, we need to reform our regulatory system to bring latest innovation faster to patients

Prosperity, health, competitiveness, resilience. These are among the priorities for European industrial policy. At the same time, becoming more sustainable, environmentally and fiscally, can support EU economic security and preparedness goals.

It is a lot to ask, but I firmly believe our medical technology sector is well-placed to deliver on all fronts. Indeed, we are already making great progress. However, I also know that, with the right policy support and regulatory reforms, we can do even more.

Early summer, at the EU Industry Days 2025, led by European Commission's DG Grow and held in Rzeszów under the Polish Presidency of the Council of the EU, I had the pleasure of discussing some of the ways medtech is driving growth in Europe.

There is a lot to be proud of. Healthcare is undergoing a revolution. From digitalisation to AI, and from robotics to minimally invasive surgery, our companies are driving changes that benefit patients, reduce the burden on healthcare professionals, and bridge Europe's green goals with its urgent need for greater competitiveness. The evidence is there to see: Europe's 38,000 medical technology companies file a patent every 30 minutes.

At the same time, we face challenges.

While I welcome the increased attention to EU competitiveness that has followed the publication of the Draghi Report, it is time for action to restore Europe's attractiveness for medtech innovation. Otherwise, we will slip backwards - losing further ground to global competitors which have become increasingly investor-friendly. Reversing the trend is key for maintaining investment, talent and the fruits of innovation.

Our competitiveness gap with other jurisdictions has widened - Let's see healthcare as an investment rather than a cost and thereby reinforce our economic resilience. One of the main reasons for this is that bringing innovation to patients takes longer in Europe than in other jurisdictions, such as the United States. It wasn't always like this, and it doesn't have to stay this way - but right now, that's the reality.

Our regulatory system is slow, inefficient and lacks good governance. Eight years into the implementation of the EU medical technology regulations, it is clearly not working. Industry and healthcare systems face device shortages, slower innovation and the potential closure of SMEs due to costly and unpredictable regulatory processes. These issues are already affecting patient care and prompting manufacturers to prioritise other markets.

Regulatory hurdles are not the only structural challenge we face. Reimbursement is complex, the adoption of value-based procurement is too slow, and austerity schemes continue to threaten access to top quality healthcare. Europe cannot continue to call for more health innovation, only to impose downward pricing pressures.

Regulatory reforms

We, in MedTech Europe, have been working hard to devise constructive and workable solutions to these challenges. There are no easy answers, but an obvious starting point is through profound systemic reform of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).

Europe must set up a single accountable governance structure; establish pathways for innovation; urgently cut red tape and costs; and ensure efficient and predictable processes throughout the system. This would lower barriers to innovation, unlocking the power of medtech to meet the needs of patients and health systems.

The upcoming targeted reform of the Medical Devices and in vitro Medical Devices Regulations by the end of the year is an opportunity to fix the current flaws - the just launched call for evidence a welcome step to further dive into the data and facts.

Health is wealth

One of the biggest roadblocks we face is the persistence of out-dated views on health spending. Smart investments in innovative health infrastructure and technologies will not only save lives, they will ultimately deliver efficienciesand strengthen our resilience.

Earmarking strategic investments in more effective, sustainable healthcare systems, supported by digital health and medical technologies means better care experiences for patients and better outcomes - and is in line with Europe's wider sustainability and digitalisation ambitions.

To achieve this, Europe should leverage the EU Multiannual Financial Framework (MFF), earmarking healthcare system funding in a new Competitiveness Fund, the Cohesion and Regional Development funds. In addition, it is vital that the next EU Framework Programme for Research and Innovation maintains health as a priority.

Looking to the future

The medical technology sector is delivering for Europe, but there are concrete actions that policymakers can take to help us do more. As we face uncertainty in global trade amid signs that our sector is losing ground, it is time for the EU and its Member States to take control of the things that are within their power: the regulatory system, the innovation ecosystem and health system investments.

The result, if we can work together to meet these challenges, will be a healthier, wealthier, more resilient and more competitive Europe.