Strategic Partner for
EU Market Access
- Importer and Distributor Services
- Authorized Representative and Regulatory Compliance
- Clinical Trial Management
- Regulatory Support for
- MDR (Medical Devices Regulation EU 2017/745)
- IVDR (In Vitro Diagnostics Regulation EU 2017/746)
- GPSR (General Product Safety Regulation EU 2019/1020)
How do we help you enter the EU market?
Riomavix is an independent company established in 2018 to support manufacturers aiming to enter the European market under the new MDR/IVDR regulations. Previously, Riomavix operated as an agency specializing in international trade across various sectors. Our work philosophy is highly practical and solution-oriented. We adapt to the specific needs of each client to provide the most effective solutions with full assurance and compliance.
MEDICAL DEVICES FROM CHINA
Enter the European market
We simplify the process for manufacturers entering the European market under the new MDR and IVDR regulations. Riomavix offers a wide range of flexible solutions, allowing you to choose the cooperation model that best fits your needs:
- Authorized Representative Services
- Clinical Trial Management
- Logistics and Distribution Solutions
WHY CHOOSE RIOMAVIX?
Seamless access to the European market without fixed costs or the need to establish your own infrastructure.
- A 100% safe and flexible business model tailored for medical devices.
- We exclusively focus on medical devices, ensuring specialized service and compliance.
- All cooperation models are designed to give manufacturers maximum control and adaptability.
Why is compliance with EU regulations essential?
Our key focus is the representation and distribution of medical devices within the European Union.
Key regulatory changes in the EU
On May 2021, the European Commission implemented two major regulatory updates:
- Medical Devices Regulation (MDR)
- In Vitro Diagnostic Medical Devices Regulation (IVDR)
These new regulations were introduced to modernize EU legislation in response to medical advancements and to provide stronger protection for public health and patient safety.
They clearly define the roles and responsibilities of all stakeholders in the medical device supply chain.
Riomavix ensures full compliance with these legal requirements and takes responsibility for all formal obligations on behalf of our clients.
KEY POINTS OF THE NEW REGULATIONS
- The MDR and IVDR introduce several significant changes aimed at improving product quality, oversight, and transparency within the European market.
- Enhanced focus on safety management throughout the entire product life cycle, supported by clinical data.
- Stricter requirements for the designation of notified bodies, ensuring greater reliability in certification processes.
- Increased control and oversight by national competent authorities and the European Commission.
- Clearer definitions of responsibilities for manufacturers, authorized representatives, importers, and distributors.
- Greater transparency, requiring that information about products, clinical investigations, and performance studies be publicly available to demonstrate regulatory compliance.