Your gateway towards the European medical devices market
Welcome to Medicina Legatis, your European representative dedicated to ensuring that your non-European medical devices meet stringent EU regulations. With our expertise in regulatory compliance and our distribution services, we facilitate your access to the European market while allowing you to focus on innovation.
As a manufacturer of medical devices outside the EU, compliance with EU regulations is essential for market access. Medicina Legatis acts as your EU Authorized Representative, ensuring that your products comply with the Medical Device Regulation (MDR). We manage your compliance, registration in the EUDAMED database, and communication with the relevant authorities.
MDR compliance : We ensure that your devices meet the requirements of European regulations.
EUDAMED registration : We take all the necessary steps to ensure that your products are correctly listed in the EU medical device database.
Post-market follow-up : Our team continues to support you post-market to ensure you are compliant with regulatory updates.
Medicina Legatis also specialises in the distribution of medical devices on the European market. Whether you're an international company looking to access new markets, or you're looking to establish a solid distribution network in Europe, we're your key partner. Thanks to our network, we can ensure smooth and compliant product distribution.
Optimised logistics : Our distribution experience ensures that your products reach European practitioners quickly and efficiently.
Strong partnership : We work with specialist distributors to provide complete coverage of the European market.
Ongoing support : From initial delivery to stock management, we're with you every step of the way.
Founded in 2021, Medicina Legatis is responsible for representing medical technology companies in Europe, with strategic proximity to the European institutions. We act as an authorised representative (EAR) for companies based outside the EU, ensuring that their medical devices comply with European regulations (MDR). We support you throughout the process to ensure a successful entry into the European market.
Why choose us?
Our team of regulatory experts works diligently to ensure that your products meet the highest standards. As your European representative, we manage all aspects of your compliance, enabling you to enter the European market without hindrance. Whether it's audits, registrations or communications with the authorities, Medicina Legatis is your key to smooth market entry.
Thanks to our extensive network and expertise in complying with regulatory standards, we make it easier for your products to access the European market. Our personalised approach guarantees optimum management of your distribution operations, while ensuring the ongoing compliance of your devices over the long term.
Spirecut - Surgical tools
Spirecut is a key player in the field of innovative surgical tools used for specific surgical procedures such as carpal tunnel release and spring finger treatment. We worked closely with them to ensure the regulatory compliance of the devices and their distribution on the European market. As a result, their range of tools was able to gain rapid and secure access to the market thanks to our expertise in European representation.
Swibrace is a Swiss manufacturer specialising in 3D-printed medical splints, combining innovation and ergonomics for patients suffering from injuries or requiring orthopaedic correction. We supported Swibrace in bringing their products into line with European standards, and helped them establish themselves on the European market. Thanks to our expertise, their devices were quickly adopted by healthcare professionals.
Swibrace - Sonosolutions develops wireless ultrasound scanners for high-precision medical diagnosis in emergency situations and clinics. We have not only helped Sonosolutions to comply with new European regulations, but also to expand their market presence as authorised distributors. These portable, affordable ultrasound scanners have become an indispensable solution for many practitioners.
If you can't find the answer to your question, please contact us at contact or consult the rest of our FAQ.
What is a European Authorised Representative (EAR)?
A European Authorised Representative (EAR) is an entity located in the EU that acts on behalf of non-European medical device manufacturers to ensure compliance with EU regulations.
What types of medical devices are covered by Medicina Legatis?
We work with a wide range of medical devices, from diagnostic technologies to surgical equipment. We guarantee that all types of non-European medical devices comply with European standards.
Managing consent
To provide the best experiences, we use technologies such as cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behaviour or unique IDs on this site. Failure to consent or withdrawal of consent may adversely affect certain features and functions.
Functional
Always active
Technical access or storage is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of transmitting a communication over an electronic communications network.
Preferences
Technical access or storage is necessary for the legitimate purpose of storing preferences not requested by the subscriber or Internet user.
Statistics
Storage or technical access used exclusively for statistical purposes.Technical storage or access which is used exclusively for anonymous statistical purposes. In the absence of a subpoena, voluntary compliance by your internet service provider or additional records from a third party, information stored or retrieved for this sole purpose cannot generally be used to identify you.
Marketing
Technical access or storage is necessary to create profiles of Internet users in order to send advertisements, or to track the user on a website or on several websites with similar marketing purposes.
EN 
FR_FR 
NL 
ZH 
NL_NL