The European Commission has proposed an ambitious package of measures to improve EU citizens’ health and ensure the healthcare sector’s long-term resilience and competitiveness.

The package includes a Biotech Act, revised rules for medical devices, and a Safe Hearts Plan, all of which will:

• strengthen the EU biotechnology sector;
• accelerate the development of innovative new treatments and therapies;
• make rules for the development of medical devices from lab to market simpler and more efficient for EU companies, while ensuring a very high level of patient safety; 
• tackle Europe’s leading cause of death, cardiovascular diseases, with a comprehensive EU approach to prevent, detect, and treat them in time.

Together, these initiatives will contribute to a more modern, efficient, and resilient health ecosystem for all EU citizens, while incentivizing growth and innovation in this strategic sector.

“Strong healthcare is a top priority for our citizens and key for a resilient Europe,” said Teresa Ribera, executive vice president for Clean, Just and Competitive Transition. “Our commitment is clear: to uphold high health standards, improve prevention and treatment options, broaden access to innovative medical devices, and empower citizens to control their health effectively. By thoughtfully incorporating innovation, streamlining processes, and investing in research and technology, we are dedicated to creating a modern, dynamic, equitable and resilient healthcare sector that benefits all Europeans.” 

Biotech Act

Biotechnology is one of the fastest-growing sectors in the EU. It currently accounts for more than 900,000 jobs—75% of which are in the health sector—and contributes close to €40 billion to the European economy. Biotech can revolutionize healthcare, as a source of groundbreaking new treatments and therapies, more precise diagnoses, and personalized medicines. However, as clearly noted in the Draghi report, the EU is lagging behind global competitors in this area due to insufficient funding, regulatory bottlenecks, and barriers to innovation.

The proposed Biotech Act will increase Europe’s biotechnology potential by supporting the transition of innovative ideas from laboratory to market. It will explore new means of funding and investment for biotech companies through a new health biotech investment pilot to be developed in cooperation with the EIB Group. It will aim to boost bio-manufacturing via targeted support.

The Act will incentivize companies to conduct research and production within Europe, accelerate clinical trials authorizations across countries, and fast-track the development of cutting-edge new therapies using artificial intelligence (AI), data, and regulatory sandboxes. Furthermore, it will simplify EU regulations to reduce costs and burdens for companies. For complex innovative products, it will establish single regulatory pathways. Ultimately this Act aims to build a world-leading health biotech industry that delivers for European patients.

“Aging populations and the rising burden of chronic diseases hugely challenge our very healthcare systems based on universal coverage. Safeguarding these systems requires innovative therapies,” stated Olivér Várhelyi, commissioner for Health and Animal Welfare. “Innovation is crucial in preventing disease, enhancing diagnostics, and addressing chronic and emerging conditions. When innovation happens in Europe, new treatments reach European patients faster and at an affordable cost, which is essential for robust, world-class care. This is why we are unlocking a new era of growth in the health sector with the Biotech Act, making Europe a global hub for health biotechnology. We are making it easier and faster to get life-saving medical devices to patients, and tackling Europe’s biggest killer—cardiovascular disease— with our ambitious Safe Hearts Plan.” 

Safe Hearts Plan

Cardiovascular diseases are the leading cause of premature death in the EU and they are preventable. They kill 1.7 million Europeans annually. Without urgent action, cardiovascular diseases are projected to rise by 90% by 2050.  Furthermore, cardiovascular diseases cost the European economy €282 billion annually.

The Safe Hearts Plan is the first comprehensive EU approach to tackling this public health challenge. It presents targeted measures to improve prevention, detection and treatment of cardiovascular diseases.

The Plan improves heart health by helping individuals with personalized disease prediction tools and therapies while addressing risk factors like tobacco, unhealthy diets, and alcohol. It seeks to bridge research gaps and integrate data, digital solutions and artificial intelligence to strengthen health systems. With levels of early cardiovascular deaths varying significantly across EU countries, the Plan emphasizes reducing health inequalities and improving access to healthcare and therapies. For example, the Commission will support Member States in developing national cardiovascular health plans, establish dashboards monitoring health inequalities, and launch an Incubator to speed up the use of AI. Beyond public health benefits, the Safe Hearts Plan also strives to bolster the EU economy and stimulate innovation in cardiovascular care, with clear goals set for 2035.

Medical Devices

The EU considers itself is a world leader in medical devices. The sector employs close to 1 million people, mostly in small and medium-sized enterprises, and the EU market is worth about €170 billion. However, current EU rules are creating unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients.

Today’s proposals will simplify EU rules for medical devices, support the digitalization of procedures, and offer a coherent framework so companies can respond to changing market conditions and patient needs. To accelerate access to medical devices and guarantee a continuous supply, timelines to complete conformity assessments will be introduced.

A stronger role for the European Medicines Agency (EMA) will strengthen coordination at EU level while companies will be offered more scientific, technical and regulatory expertise. The EMA will also monitor shortages of medical devices, and a list of critical devices will be created. The reform will ensure that patient safety remains the highest priority, while enabling faster access to safe and innovative devices and strengthening the EU’s competitiveness in this vital sector. Finally, the proposal will ensure uniform and coherent rules for medical devices incorporating AI applications. Altogether, these measures should lead to overall cost savings of €3.3 billion per year, including €2.4 billion annual administrative savings.

“The EU is a global leader in medical devices. Our rules must provide clarity, predictability and flexibility to sustain that leadership and continue delivering for patients,” said Valdis Dombrovskis, commissioner for Economy and Productivity; Implementation and Simplification. “…we are simplifying procedures, cutting bottlenecks and strengthening regulatory certainty and predictability for manufacturers and public authorities, all while keeping patient safety as our top priority. This will speed up access to innovative medical devices and boost the competitiveness of a sector that is vital to Europe’s economy.” 

The legislative proposals for a Biotech Act and simplification of the Medical Devices and In vitro Diagnostics Regulations will now be submitted to the European Parliament and the Council for adoption. The Commission will also begin work with Member States to start implementing the key deliverables of the “Safe Hearts” plan.

MedTech Europe considers the European Commission’s targeted revision proposal of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as a key milestone in bringing urgently needed reforms to Europe’s medical technology sector and for patients.

The MDR and IVDR have each strengthened the EU regulatory system for medical technologies. At the same time, their structural deficiencies have led to serious unintended consequences, including certification bottlenecks, reduced availability of products for patients, and unsustainable pressure on small and medium-sized enterprises (SMEs). Revising what is not working well, while preserving what already functions effectively, is therefore both necessary and timely.

While the European Commission proposes solid improvements in governance and system resourcing, it misses the opportunity to provide for a single—rather than fragmented—governance structure that is accountable for ensuring that a full range of safe and performing devices are available for patients in a timely way, according to MedTech Europe.

“This revision is a long-awaited and necessary step to fix parts of the EU regulatory system that are clearly not working for patients, innovators and healthcare providers,” MedTech Europe CEO Oliver Bisazza said. “Significant system improvements are needed to make it more efficient, innovation friendly and well-governed. With the right reforms and investment, Europe can once again lead in inventing, launching and ensuring patient access to medical technology innovation. The task now for the European Parliament and the Council is to fully seize this opportunity in the final legislation.”