SCIENCE. TECHNOLOGY. BETTER LIFE.
Innovative medical solutions for a healthier tomorrow.
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Bringing trusted medical solutions to markets worldwide.
Bringing trusted medical solutions to markets worldwide.
More than a decade of expertise in medical regulatory strategy and healthcare markets.
More than a decade of expertise in medical regulatory strategy and healthcare markets.
We support healthcare professionals and institutions with technology designed for real-world clinical needs.
We support healthcare professionals and institutions with technology designed for real-world clinical needs.
The European Medical Device Regulation (EU MDR 2017/745) requires manufacturers to demonstrate that their medical devices meet defined requirements for safety, performance and clinical benefit before placing them on the European market. We guide manufacturers through the complete MDR compliance pathway and help establish the regulatory strategy appropriate to their device, classification and intended purpose.
Our services cover device classification, regulatory strategy, technical documentation, risk management, clinical evaluation, Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), quality management systems and CE marking. Where Notified Body involvement is required, we support the preparation and coordination of the assessment process, helping manufacturers address regulatory gaps efficiently and avoid unnecessary delays.
For medical device manufacturers established outside the European Union, appointing an EU Authorized Representative is a fundamental requirement under the MDR. FENARIS acts as the manufacturer’s regulatory partner within the European market, supporting compliance and maintaining the required regulatory interface with European authorities. We provide EU Authorized Representative services, regulatory communication, technical documentation support, vigilance and incident reporting, registration and database coordination, and ongoing MDR compliance support.
We offer a highly curated portfolio of advanced medical technologies, carefully selected for their innovation, clinical value, quality and potential to make a meaningful difference in modern healthcare.
We focus on a limited number of high-performance technologies that meet demanding medical and quality requirements. Our portfolio spans a broad spectrum of healthcare applications from advanced medical equipment designed for intensive care units and professional hospital environments to innovative, easy-to-use devices intended for everyday healthcare and home use.
We work directly with selected manufacturers, making these technologies available through a trusted and controlled supply chain. Every product undergoes careful evaluation before becoming part of our portfolio, with particular attention to medical quality, safety, performance, regulatory compliance and practical clinical value.
Our Market Access Services enable manufacturers to commercialize their products seamlessly across the European Union by combining regulatory compliance with established distribution capabilities. Expand your product sales across the EU with confidence.
We can coordinate tailored clinical investigations through a network of experienced CRO partners, including support for EU MDR Class III medical devices. We ensure regulatory-aligned study design, efficient trial execution, and compliant data generation to support conformity assessment.
Our Training Programmes for Nurses and Doctors provide structured, device-specific education on the safe use of novel medical devices in clinical settings. Training is aligned with EU MDR requirements and supports proper adoption and clinical performance optimization.
Exhibitions and conferences
Exhibitions and conferences
It was our pleasure to meet new clients at the Dubai World Health Expo 2026, where we presented our regulatory, certification, and market access services for medical device manufacturers. Connect with us in person to discuss EU MDR compliance, clinical strategies, and European market entry. Our next WHX event will take place in Johannesburg in October, 2026. More details coming soon!
ABOUT US
Fenaris operates at the nexus of innovation and influence, guiding Asian companies on their journey to penetrate global markets. Our footprint spans across Europe, the USA, the Middle East, India, and Africa, driving access to critical procurement channels and facilitating seamless market entry. We are more than just a business facilitator. We support medical device manufacturers throughout the entire product lifecycle, from regulatory strategy and conformity assessment to commercialization and post-market activities across the globe.
During the pandemic, when the world faced critical shortages, our expertise came to the forefront. Fenaris representatives were pivotal in the central procurement of vaccines, personal protective equipment, and medical supplies, forming essential partnerships with hospitals and supply chains globally. Today, we continue that legacy, connecting Asian innovators in sectors as diverse as pharmaceuticals, medical devices, and cutting-edge technologies to the world’s most complex markets. Our alliance is about opportunity, strategic access and direct connections in the global market.
FAQ
Do I need an EU Authorized Representative?
Do I need an EU Authorized Representative?
If your company is outside the EU, you must appoint an EU Authorized Representative before selling medical devices in Europe.
How long does MDR certification take?
How long does MDR certification take?
Low-risk devices may take a just a few months, while higher-risk devices can take up to 12–14 months.
What does your MDR certification package cost?
What does your MDR certification package cost?
The total cost depends on the device type, classification and applicable conformity assessment route. However, our MDR certification packages typically range from €40,000 to €70,000.
What documents are needed for MDR compliance?
What documents are needed for MDR compliance?
Core documents include technical documentation, risk management file, clinical evaluation report, labeling and IFU, and post-market surveillance documentation.
Do we need to translate our documentation before starting the MDR certification process?
Do we need to translate our documentation before starting the MDR certification process?
No. You do not need to translate your documentation in advance. We can work with your original documentation. The required translations are included in our MDR certification package.
Can Fenaris help with MDR compliant document creation?
Can Fenaris help with MDR compliant document creation?
Yes. We support generating MDR compliant Technical File and QMS Documentation. While some QMS documents are the sole responsibility the manufacturer, many documents can be created by Fenaris, if the required amount of technical information is available.
How do we start?
How do we start?
Contact our Budapest office for an initial consultation. We review your device and define a clear MDR compliance and EU market entry strategy. Upon mutual agreement, we will carry your company through the entire procedure, from the point of MDR application, to promotion and distribution of your products after obtaining MDR approval.
CONTACT US
Global expertise. Local presence.
FENARIS operates through a strategic international network, with our European operations and core regulatory activities based in Budapest, supported by our Head Office in Canada and our Asia-Pacific presence in Seoul.
EUROPEAN OPERATIONS & REGULATORY OFFICE — BUDAPEST, HUNGARY
T: +36 30 090 1320
HEAD OFFICE — TORONTO, CANADA
T: +1 613-941-5366
ASIA–PACIFIC OFFICE — SEOUL, SOUTH KOREA
T: +82 10-7650-7749
For general enquiries and business opportunities:
info @ fenaris . com
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