We assist manufacturers worldwide in understanding and meeting European regulatory obligations smoothly and efficiently
Professional EU representation services for non-European medical device manufacturers under MDR and IVDR regulations
Guidance and support for meeting Medical Device Regulation requirements across all device classes.
Specialized compliance assistance for in-vitro diagnostic medical devices entering the European market.
Support for Unique Device Identification implementation, labeling, and traceability requirements.
Complete assistance with SRN applications, actor registration, and device registration processes.
Professional review of technical files, declarations, risk management documents, and compliance records.
Step-by-step support for achieving CE marking and maintaining conformity with European standards.
Expert consultation services to help manufacturers understand and manage regulatory obligations.
Nexus Global acts as your professional EU Representative and supports your compliance journey within the European market.
Medical device classification under MDR defines the regulatory requirements for a device. It determines the CE marking route, technical documentation, and conformity assessment process.
UDI (Unique Device Identification) improves medical device traceability, transparency, and patient safety under MDR and IVDR requirements.
EUDAMED is the European Database on Medical Devices developed to improve transparency and regulatory coordination within the European market.
Helping medical device manufacturers achieve European compliance with confidence, accuracy, and professional regulatory support.
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