EUROPE – Overview of Medical Device Industry and Healthcare Statistics

Below you will find basic demographic and healthcare market data on Europe, plus specific information about the medical device and healthcare industries.

Overview of medical device industry: The medical device market in the EU accounts for one third of the global market, with around $122.5 billion (est. 2011) in yearly revenue. The industry consists of over 22,000 companies all over Europe that employ around half a million people.

Many European countries are leaders in medical device innovation and export their products all over the world. Germany, France, and Sweden are very competitive in other markets as well as in Europe.

Opportunities in the European market: Europe is a major hub for the global medical device industry. However, many European countries export their products to the other markets, and rely on imports to supply the domestic healthcare industry. Manufacturers producing in-demand technologies will find their products are well-received.

Industry challenges in Europe: Recent regulatory, economic, and political shifts in Europe could impact the medical device industry. The medical device manufacturers will transition to the new Medical Device Regulations and ISO 13485:2016, placing significant pressure on Notified Bodies. The relatively weak Euro continues to benefit European companies exporting to the US, but creates difficulties for some importers. Foreign manufacturers will continue to compete with large, multinational corporations operating and distributing in Europe. And, it is important to research the countries where your product will perform best, as healthcare industries vary significantly from one country to the next.

How Europe compares to other markets

Want to see how Europe compares to many other markets around the world? Download our free PDF Healthcare spending by country.

Related services:

• CE Mark Certification for Medical Devices
• Clinical Evaluation Reports (CER) for Medical Devices in Europe
• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR Compliance Consulting for Cosmetic and Aesthetic Products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
• European MDR 2017/745 Gap Assessment and CE Transition Strategy
• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
• Medical Device and IVD Emergency Use Routes in Europe
• Medical Device Technical File and Design Dossier for EU CE Marking
• Switzerland Representative for Medical Device Companies
• UKRP and Brexit Consulting for Medical Device Companies