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Deviceology - The EU Market Access People

Deviceology is adept at steering clients through the expansive and opportunity-rich landscape of the European Union's Medical Devices sector. Capitalising on our experience with international regulations and ISO standards, notably ISO 13485 for quality management systems, we deliver a full spectrum of services to simplify your market entry.

Our experts offer essential guidance on complying with the stringent regulatory framework overseen by the European Medicines Agency (EMA) and adhering to the EU Medical Device Regulation (MDR 2017/745). We also provide comprehensive guidance on CE marking, a mandatory conformity marking for products sold within the European Economic Area (EEA).

What sets the EU market apart is its sheer size and untapped potential. With a population exceeding 447 million and a healthcare expenditure that ranks among the highest globally, the EU presents a fertile ground for medical device manufacturers. Our market intelligence services are designed to uncover these opportunities, focusing on burgeoning sectors like cardiology, orthopedics, and telemedicine, which are gaining traction due to the EU's diverse and ageing population.

Our integrated solutions, from in-depth market analysis to product launch, are meticulously crafted to meet both international and EU-specific standards. This includes a nuanced understanding of the EU's healthcare policies, funding mechanisms, and the complexities of operating across multiple member states.

By forging a partnership with Deviceology, clients can expect a streamlined, compliant, and strategically advantageous entry into the EU's highly lucrative Medical Devices market.

Market Data

Medical Devices Market Valuation

2023: projected to reach a valuation of US$136.30 billion

2028: projected to reach a valuation of US$167.60 billion

Annual growth rate of 4.22%

Market Segmentation

  • Cardiovascular Devices

  • Orthopedic Devices

  • Diagnostic Imaging Devices (AI Prevalent)

  • In-Vitro Diagnostics (IVD)

  • Minimally Invasive Surgery Devices (AI Prevalent)

  • Wound Management Devices

  • AI-Driven Diagnostic and Monitoring Devices (AI Prevalent)

  • Robotic Surgery Systems (AI Prevalent)

Healthcare Expenditure

Healthcare expenditure varies significantly among EU Member States. Germany had the highest healthcare expenditure relative to GDP at 12.8%, followed by France at 12.2%.

  • Shifting Regulatory Landscape: Competitive advantage for those who navigate regulations effectively.

  • Robotic Surgeries: Growing market with high demand for accuracy and efficiency.

  • AI and Machine Learning: Rapidly expanding market with increasing regulatory approvals.

  • Remote Patient Monitoring: High growth potential for managing chronic conditions.

  • 3D Printing: Expanding applications in surgical planning, training, and orthotics.

  • Cybersecurity: Increasing importance due to the rise of connected devices.


Market Dynamics

  • Regulatory Shifts: Implementation of MDR 2017/745 has increased quality and safety standards, leading to higher R&D investments.

  • Market Consolidation: Mergers and acquisitions are a key strategy for gaining a competitive edge.

  • AI and ML Influence: Rapid expansion in AI/ML medical devices, with increasing CE marked approvals.

  • Digital Health Focus: The EU's emphasis on digital health is driving data-driven healthcare solutions.

Contact us to discuss your access requirements for the European Union's Medical Devices market

Deviceology - The Market Access People

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