Europe’s MedTech Landscape in 2025: 38,000+ Companies Driving Innovation
Europe is home to one of the world’s most dynamic and diverse medical technology ecosystems, with more than 38,000 MedTech companies operating across the continent. The vast majority—over 90%—are small and medium-sized enterprises (SMEs), playing a critical role in driving innovation, improving healthcare outcomes, and fueling economic growth .
What Defines Europe’s MedTech Industry?
According to MedTech Europe, the sector includes manufacturers of medical devices, in vitro diagnostics (IVDs), and digital health solutions, spanning everything from surgical tools to AI-powered diagnostic platforms. In total, the industry employs over 930,000 people directly, making it one of the largest employers in Europe’s life sciences space .
Why It Matters for Clinical and Regulatory Success
With the growing complexity of EU MDR and IVDR regulations, these companies—especially SMEs—face increasing pressure to:
- Prove clinical evidence and safety of their technologies
- Navigate Notified Body reviews and CE Marking
- Manage post-market surveillance (PMS) and performance evaluations
That’s where MDx CRO steps in.
Supporting Europe’s MedTech Growth
At MDx CRO, we specialize in helping MedTech innovators—from start-ups to established manufacturers—successfully plan, execute, and submit their clinical and regulatory strategies across the EU and global markets. With proven expertise in:
- IVD & Medical Device clinical trials
- Regulatory affairs under MDR/IVDR
- Risk management & documentation
- Software as a Medical Device (SaMD) compliance
- ISO-standard training & quality support
We partner with both large diagnostic leaders and agile SMEs to deliver compliant, high-quality, and market-ready solutions.
A Pan-European Presence
With offices in Barcelona, Madrid, Lisbon, and London, and a network of CRAs and regulatory experts across Europe, MDx provides localized insight with global reach—helping MedTech companies meet requirements faster and smarter.
The Bottom Line
The European MedTech sector is growing—but so are its regulatory challenges. Whether you’re launching a new diagnostic product or preparing for a Notified Body audit, MDx CRO is here to support your success every step of the way.
