Medicina Legatis was founded in 2021 to represent Swiss Medical Technology companies in Belgium, close to the European institutions. In order to sell medical devices in any EU member state, manufacturers not based in the EU must appoint a European representative, also known as an Authorized Representative, as mandated by the European Medical Device Regulation (MDR), which took effect in May 2021.
Medicina Legatis, which means "Ambassador of Medicine" in Latin, can provide this service if you require a European Representative. Medicina Legatis offers high standard of services to manufacturers of medical devices based in non-European countries.
Welcome to Medicina Legatis: Your Gateway to European Medical Device Compliance
At Medicina Legatis, we take pride in guiding international medical device manufacturers through the intricacies of the European Union's (EU) regulatory landscape. With the implementation of the Medical Device Regulation (MDR) in May 2021, navigating the EU market has become more demanding than ever. That's where our expertise as European Authorized Representatives (EARs) comes into play.
Why Choose Us?
As your dedicated EAR, we serve as your local gateway to the EU market. Our team of seasoned professionals ensures that your medical devices comply with the MDR's essential requirements and technical standards, paving the way for a seamless market entry. Medicina Legatis specializes in navigating the complexities of the MDR, managing all aspects of regulatory compliance on your behalf.
Smooth Market Entry
Getting your medical devices onto the EU market can be challenging without the right guidance. With us as your EAR, you can expedite the registration process and access the EU market efficiently, while maintaining the highest safety and performance standards.
Our commitment doesn't end at market entry. We stand by your side throughout the entire product lifecycle. From post-market surveillance to handling incident reporting, our team ensures that your devices continue to meet regulatory requirements long after they reach the market.
Expert Communication with Authorities
Communicating effectively with EU competent authorities is crucial. As your EAR, we act as a reliable liaison, promptly addressing inquiries and facilitating seamless communication with the authorities.
EUDAMED Registration Made Easy
Rest assured that your medical devices will be accurately registered in the EU's EUDAMED database. Our streamlined processes ensure enhanced transparency and seamless tracking of your devices throughout the EU.
Your Trusted Partner
At Medicina Legatis, we understand that every manufacturer is unique. Our personalized approach ensures tailored solutions that best suit your specific needs. Count on us to be your trusted partner in achieving EU medical device compliance.
Contact Us Today
Ready to conquer the European market with confidence? Let our team of experts at Medicina Legatis be your guiding light. Contact us today to embark on a journey toward regulatory success in the EU market.