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In mid-December 2025, the European Commission proposed an ambitious package of measures to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the EU-wide health sector.
Background
The biotechnology package includes: a) the Biotech Act, as the revised rules for medical devices, and b) the so-called “Safe Hearts Plan”; thus, the package will aim at reaching the following goals:
= strengthen the EU biotechnology sector;
= accelerate the development of innovative new treatments and therapies for patients;
= 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.
Taken together, these initiatives will contribute to a more modern, efficient, and resilient health ecosystem for all EU citizens, while incentivising growth and innovation in this strategic sector.
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 revolutionise healthcare, as a source of ground-breaking new treatments and therapies, more precise diagnoses and personalised medicines. However, as clearly pointed out in the Draghi report, the EU is lagging behind global competitors in this area, due to insufficient funding, regulatory bottlenecks and barriers to innovation.
Biotechnology is pushing forward science and revolutionising industry: i.e. it is crucial for advancing public health and spurring economic growth.
The European Commission aims to position the EU as a leader in biotechnology by advancing R&D, fostering an ecosystem where biotech innovation can thrive and boosting the growth potential of biotech companies in the EU.
Of the mentioned 40 billion that the biotechnology sector adds to the EU’s economy, more than 80% comes from health biotechnology. 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.
More in: https://health.ec.europa.eu/biotechnology_en
The Act will incentivise companies to conduct research and production within Europe, accelerate clinical trials authorisations across countries, and fast-track the development of cutting-edge new therapies using 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 today’s Act aims to build a world-leading health biotech industry that delivers for European patients.
More on the “proposal for a Regulation to establish measures to strengthen the Union’s biotechnology and biomanufacturing sectors (European Biotech Act)”, in: https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en
Medical devices
The EU is a world leader in medical devices; the sector employs close to one million people, mostly in small and medium-sized enterprises, and the EU market is worth around €170 billion. However, current EU rules are creating unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients.
More in: https://ec.europa.eu/commission/presscorner/detail/en/fs_25_3072
Present proposals will simplify EU rules for medical devices, support the digitalisation of procedures, and offer a coherent framework so that companies can respond to changing market conditions and patient needs. To speed up 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.
More on the proposal for a regulation on medical and in vitro diagnostic devices in:
https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
Mobilising investments
The European Commission and the European Investment Bank (EIB) Group have today announced an initiative to mobilise €10 billion in investment in 2026-27 into the biotech and life sciences sector. The project aims to give a significant boost to the EU’s competitiveness in biotechnology, by addressing the EU’s current investment gap and mobilising public-private investment into promising new health solutions.
Biotech can revolutionise healthcare, by delivering ground-breaking medicines and treatments to patients, such as AI-driven cardiac sensors to monitor for heart failure, mRNA therapies or monoclonal antibodies to help the immune system to spot harmful cells quickly. It is at the core of pioneering work in gene therapies, personalised medicine and biopharmaceuticals, such as synthetic insulin.
More in: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3096
Next Steps
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. We will also begin work with Member States to start implementing the key deliverables of the “Safe Hearts” plan.