We ensure your compliance with strict EU standards.
Our representation services
At Medicina Legatis, we act as your gateway to the European market. Non-European companies wishing to sell their medical devices within the European Union must appoint an Authorised Representative. That's where we come in: thanks to our expertise, we can help you navigate European regulations, ensuring that your products comply with strict market requirements.
In accordance with the requirements of the European Medical Device Regulation (MDR), all medical devices marketed in Europe must bear the CE conformity mark. This marking guarantees that the device complies with the essential safety and performance requirements for all classes of medical device. It is followed by the number of the notified body responsible for conformity assessment (except for Class I devices). However, certain exceptions apply, in particular for devices used as part of a clinical investigation. Medicina Legatis checks that these obligations are met when new devices are introduced to the European market.
MDR - Medical Devices Regulation
Since May 2021, the Medical Device Directive (MDD) has been replaced by the European Medical Device Regulation (MDR), unifying the rules for the marketing of devices within the European Union. This regulation introduces strict requirements to guarantee the safety of users and patients. Non-European manufacturers must comply with these new regulations in order to access the European market.
For more details, the full text is available on the official website of the European Union via the link below.
We manage the entire compliance process, from checking regulatory requirements to providing support during inspections. We ensure that your products comply with current European standards.
Interaction with the competent authorities
As the European Representative, we act as the main point of contact between your company and the health authorities in the various EU Member States. This includes communicating during inspections and managing incident reports.
EUDAMED
We manage the registration of your medical devices in the European medical devices database (EUDAMED). This includes regular updates and monitoring of information relating to your products.
Post-marketing assistance
Our role doesn't stop once your products enter the European market. We offer post-market follow-up to ensure that your devices continue to meet regulatory requirements, including incident reporting and ongoing monitoring.
Our representation services
At Medicina Legatis, we act as your gateway to the European market. Non-European companies wishing to sell their medical devices within the European Union must appoint an Authorised Representative.
CE marking
CE marking: a compulsory requirement for access to the European market.
MDR - Medical Devices Regulation
Strict regulations to guarantee the safety of medical devices in Europe.
In accordance with the requirements of the European Medical Device Regulation (MDR), all medical devices marketed in Europe must bear the CE conformity mark. This marking guarantees that the device complies with the essential safety and performance requirements for all classes of medical device. It is followed by the number of the notified body responsible for conformity assessment (except for Class I devices). However, certain exceptions apply, in particular for devices used as part of a clinical investigation. Medicina Legatis checks that these obligations are met when new devices are introduced to the European market.
Since May 2021, the Medical Device Directive (MDD) has been replaced by the European Medical Device Regulation (MDR), unifying the rules for the marketing of devices within the European Union. This regulation introduces strict requirements to guarantee the safety of users and patients. Non-European manufacturers must comply with these new regulations in order to access the European market.
Key points of the MDR include:
- Precise definition of medical devices and accessories (including medical software). - Registration procedure for manufacturers and obligations for importers and distributors. - Obligation to appoint a European representative for non-European manufacturers, such as Medicina Legatis. - Appointment of a person responsible for regulatory compliance (PRRC). - CE marking, Unique Device Identification (UDI) and registration in the European database (EUDAMED). - Organisation of clinical investigations. - Post-trade surveillance and data protection.
The MDR also applies to clinical investigations involving medical devices.
For more details, the full text is available on the official website of the European Union via the button below.
As European representatives for non-European manufacturers of medical devices, we offer you unique expertise in regulatory compliance and CE marking. Our tailor-made solutions give you rapid and secure access to the European market. We stand out for our responsiveness, our network of competent authorities, and our perfect command of the requirements of the European Medical Device Regulation (MDR).
Regulatory Expertise
We have in-depth knowledge of MDR regulations, ensuring that your products comply with strict EU standards.
Flexibility and availability
We adapt to your needs, offering a service tailored to the size of your company and the type of medical devices you sell.
Reactivity
As European Representative, we ensure rapid exchanges with the competent authorities and provide you with regular reports on the conformity of your products.
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