MedTech Europe has published its 2026 Facts & Figures report, providing an updated overview of the European medical technology sector across regulation, innovation, digital health, sustainability, employment, companies, healthcare expenditure, market size and international trade.
The report portrays a sector that remains highly innovative and economically significant, but is facing increasing pressure from slower market growth, regulatory complexity, procurement constraints and declining global market share.
According to MedTech Europe, employment has now exceeded 950,000 people, patent activity remains historically high, and medical technology continues to demonstrate strong innovation performance. At the same time, Europe’s share of the global medtech market fell to 25.6% in 2025, compared with 26.4% one year earlier and close to 29% in 2015.
More Than Two Million Medical Technologies
The European medical technology landscape includes a wide range of products, from everyday healthcare products to sophisticated implantable and diagnostic technologies.
MedTech Europe identifies three main categories:
medical devices;
in vitro diagnostics;
digital health solutions.
The report estimates that there are more than 2 million medical technologies, classified into more than 7,000 generic device groups, used across hospitals, community care and home environments.
Regulatory Complexity Remains a Major Issue
Medical technologies in the EU are primarily regulated under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
However, MedTech Europe notes that approximately 70 to 80 additional EU regulations and directives can also affect the sector, including legislation covering:
artificial intelligence;
data protection;
the European Health Data Space;
electromagnetic compatibility;
machinery;
public procurement;
product liability;
hazardous substances.
This increasingly interconnected regulatory environment is particularly relevant for digital and AI-enabled technologies.
MDR and IVDR Revision Seen as a Major Opportunity
MedTech Europe identifies the ongoing revision of the MDR and IVDR as an important opportunity to improve the European regulatory environment.
The report argues that regulatory reform should restore greater speed and predictability while maintaining patient safeguards.
The organisation also highlights challenges faced by AI-enabled medical technologies, which may simultaneously need to comply with medical device regulation, the AI Act, cybersecurity rules, data protection requirements and the European Health Data Space.
MedTech Europe calls for better coordination between these frameworks and argues that compliance already demonstrated under MDR or IVDR should, where appropriate, be recognised across overlapping regulatory requirements.
Medical Technology Innovation Remains Strong
Innovation remains one of the European medtech sector’s strongest characteristics.
The report estimates average global R&D expenditure in medical technology at approximately 6.5–7% of revenue, rising to around 10% among the 100 largest medical technology companies.
In 2025, more than 15,900 medical technology patent applications were filed with the European Patent Office.
This represented a 1.3% increase compared with 2024, with medical technology accounting for 7.9% of all EPO patent applications.
Medical Technology Leads in Granted Patents
The report also highlights particularly strong patent conversion.
Medical technology recorded 12,310 granted patents in 2025, more than any other technical field covered in the report.
Its granted-to-application ratio reached 77.4%, compared with:
38.6% for pharmaceuticals;
21.5% for biotechnology.
The patent chart in the report also places medical technology fourth among the largest technical fields for European patent applications, behind computer technology, digital communication and electrical machinery.
Digital Health Reimbursement Is Expanding
Digital health is another major focus of the 2026 report.
MedTech Europe states that reimbursement for digital healthcare solutions is moving from experimentation toward more routine integration into healthcare systems.
Germany remains a leading example through the DiGA programme.
At the end of 2025:
59 DiGA were active;
50 were permanently listed;
nine remained provisionally listed;
almost 70% of provisionally listed DiGA had achieved permanent listing following the trial period.
France and Belgium are also developing reimbursement pathways for digital health and remote monitoring solutions.
Switzerland Takes First Step on Digital Health Reimbursement
The report also highlights an important development in Switzerland.
Since 1 July 2026, Switzerland’s MiGeL list of medical devices and supplies has included a dedicated chapter for digital health applications.
The first generic category covers cognitive behavioural therapy for depression.
MedTech Europe argues that as more digital solutions become AI-enabled, regulatory coherence will become increasingly important to maintain the pace of adoption and reimbursement.
Sustainability Challenges Extend Across the Supply Chain
The report estimates that global healthcare contributes approximately 5% of global greenhouse gas emissions, with medical technology representing approximately 15–25% of healthcare’s footprint, equivalent to around 1% of global emissions.
A key challenge is that only an estimated 5–10% of medtech emissions are directly controlled by companies.
The remainder is distributed across the wider value chain, including:
raw material extraction and processing;
product use;
end-of-life;
packaging.
The report therefore suggests that sustainability cannot be addressed through supplier pressure alone and will require action throughout the healthcare value chain.
European MedTech Employment Passes 950,000
The European medical technology industry now directly employs more than 950,000 people, compared with over 930,000 reported in the previous edition.
Germany has the highest absolute number of employees, while Ireland and Switzerland lead in employment relative to population.
The sector accounts for approximately 0.37% of total employment in Europe, with estimated value added of around €182,000 per employee.
The report also shows Portugal at approximately 15 medtech employees per 10,000 inhabitants.
Company Numbers Decline for the First Time
One of the most notable developments in the 2026 edition is the first year-on-year reduction in the number of European medical technology companies recorded by the report.
Europe now has more than 36,000 medical technology companies, compared with more than 38,000 in the previous edition.
MedTech Europe notes that national company figures can fluctuate and should be interpreted cautiously, but considers the change significant enough to monitor.
SMEs Represent Around 90% of the Industry
Approximately 90% of European medical technology companies are SMEs, with most employing fewer than 50 people.
This makes regulatory and economic pressures particularly important.
Smaller companies may have less capacity to absorb:
regulatory compliance costs;
price-focused procurement;
tariffs;
changes resulting from MDR and IVDR reform;
public procurement reform.
The report therefore links European competitiveness directly to whether smaller companies can continue to operate and innovate sustainably.
Medical Technology Accounts for Less Than 1% of European GDP
Europe spends an average of approximately 10% of GDP on healthcare.
Medical technology represents approximately 7.3% of total healthcare expenditure, corresponding to less than 1% of GDP.
Average medical technology expenditure is approximately €325 per person.
Of total healthcare expenditure, the report attributes approximately:
6.7% to medical devices, including imaging;
0.6% to in vitro diagnostics.
European MedTech Market Reaches Approximately €173 Billion
The European medical technology market was worth approximately €173 billion in 2025.
The five largest markets were:
Germany;
United Kingdom;
France;
Italy;
Spain.
Germany alone represented approximately 24.6% of the European medical device market, followed by the UK at 12.9% and France at 12.4%.
Europe’s Global Market Share Continues to Fall
Despite its strong industrial base, Europe represented 25.6% of the global medical device market in 2025.
The United States remained significantly larger at 47.6%.
Other major global markets included:
China — 5.4%;
Japan — 4.6%;
Canada — 1.9%;
Mexico — 1.8%;
South Korea — 1.8%.
The decline in Europe’s share is one of the main concerns raised in the report.
European Market Growth Slows to 1.8%
The European medical device market has grown by an average of 5.6% annually over the past decade.
However, growth slowed to just 1.8% in 2025, following 6.0% growth in 2024.
The chart covering 2019–2025 illustrates significant volatility, including 11.5% growth in 2022 before growth moderated substantially in subsequent years.
MedTech Europe links this slower growth to broader concerns about whether innovation can be adopted, reimbursed and scaled effectively in Europe.
IVD Market Returns to More Normal Growth
The European IVD market experienced major volatility during the COVID-19 pandemic.
Growth reached:
29.1% in 2020;
43.7% in 2021.
This was followed by declines of:
19.3% in 2022;
20.2% in 2023.
The market returned to growth in 2024 and recorded provisional growth of approximately 1.0% in 2025.
Across the past decade, the European IVD market has grown by an average of approximately 3.6% per year.
Europe Maintains a Positive Medical Device Trade Balance
Europe recorded a €4 billion positive medical device trade balance in 2025.
MedTech Europe notes that this figure cannot be compared directly with the figure published in the previous edition because the methodology for Harmonised System trade codes was substantially revised.
The United States remains Europe’s largest export destination, accounting for 36.8% of medical device exports.
China represents 10.6%, while Japan accounts for 5.0%.
United States and China Dominate European Imports
For imports into the European medical device market, the report shows:
United States — 42.2%;
China — 20.3%;
Japan — 5.7%;
Mexico — 5.0%.
These figures highlight the continued importance of international supply chains to the European medical technology market.
Significant Differences in National Trade Balances
Germany recorded the largest positive medical device trade balance among the countries shown, at approximately €18.8 billion in 2025.
Ireland followed with approximately €16.6 billion, while Switzerland recorded approximately €6.8 billion.
At the other end of the scale, several countries recorded negative trade balances, including:
Portugal — approximately €1.57 billion deficit;
Italy — €3.58 billion deficit;
United Kingdom — €3.86 billion deficit;
Spain — €6.46 billion deficit;
France — €6.53 billion deficit.
Procurement Is Becoming More Important
The report also highlights public procurement as an increasingly important element of market access.
Purchasing priorities are shifting toward:
security of supply;
long-term value;
sustainability.
MedTech Europe argues that value-based procurement will be important, particularly for SMEs facing simultaneous regulatory compliance costs and pricing pressure.
Impact on Medical Device and IVD Manufacturers
For manufacturers, the 2026 Facts & Figures report presents a mixed picture.
Europe remains a major centre for:
innovation;
research and development;
employment;
patent activity;
manufacturing;
international trade.
However, companies are operating in an environment characterised by:
slower market growth;
declining global market share;
MDR and IVDR implementation costs;
additional horizontal EU legislation;
procurement pressure;
sustainability requirements;
increasing global competition.
For regulatory teams, the report reinforces the importance of understanding compliance not as an isolated MDR or IVDR exercise, but as part of a wider regulatory ecosystem increasingly involving AI, cybersecurity, data protection, EHDS, sustainability and market-access requirements.
Regulatory Coherence as a Competitiveness Issue
One of the central messages of the report is that European competitiveness increasingly depends on regulatory coherence.
MedTech Europe argues that Europe’s challenge is not a lack of capacity to innovate, but rather ensuring that innovation can be adopted, reimbursed and scaled.
The MDR and IVDR revision therefore represents a significant opportunity to improve predictability while maintaining patient safety.
For AI-enabled technologies in particular, closer coordination between medical device regulation and horizontal digital legislation will be essential.
Outlook for the European MedTech Sector
The 2026 edition portrays a European medtech industry that remains highly innovative and economically important but faces growing competition and structural pressure.
Record employment and strong patent activity demonstrate continued industrial strength.
At the same time, slower market growth, fewer companies and declining global market share indicate that innovation alone may not be enough to maintain Europe’s competitive position.
The report’s message is therefore increasingly focused on the conditions needed to convert European innovation into patient access, sustainable growth and global competitiveness.
