ABOUT US

The Fenaris Alliance 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. 

WHY MANUFACTURERS CHOOSE FENARIS ?

• Deep understanding of EU MDR requirements

• Dedicated to Asian manufacturers

• Single point of contact for certification and market access

• Network of clinical, regulatory and distribution partners

• Support throughout the entire product lifecycle

• Multilingual communication 

• Local agents is more than 20 countries

FAQ

Do I need an EU Authorized Representative?

Yes. If your company is outside the EU, you must appoint an EU Authorized Representative before selling medical devices in Europe. 

What is EU MDR?

EU MDR (Medical Device Regulation 2017/745) is the current legal framework for medical devices in Europe. 

How long does MDR certification take?

Low-risk devices may take a few months, while higher-risk devices can take 12–18 months.

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. 

What is the role of a Notified Body?

A Notified Body is an EU-designated organization that evaluates medical devices for MDR compliance. Their approval is required before CE marking.

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.

Can Fenaris help with EU distribution?

Yes. We regularly support companies from Asia, the USA, and other regions to sell their medical devices in the European market.

Can Fenaris take the role of Authorized Representative?

Yes. We regularly act as AR and main EU contact point of our partners.

How do I start?

Contact us 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.