EU Authorised Representative
Click here to learn more about the roles and responsibilities of authorised representatives.
In Vitro Diagnostic Medical Devices
Click here to learn about In-Vitro Diagnostic Medical Devices and the IVDR.
Post-Market Surveillance
Click here to learn about various aspects of Post-Market Surveillance including Post-Market Surveillance Reports (PMSR), Post-Market Clinical Follow-Ups (PMCF) and Periodic Safety Update Reports (PSUR).
Clinical / Performance Evaluation
Click here to learn about the key aspects of the Clinical and Performance Evaluations.
Technical Documentation
Click here to learn about the technical documentation required for compliance with the MDR/IVDR.
Risk Management
Click here to learn about the application of risk management to medical devices and in-vitro diagnostic medical devices.
Advena
Advena frequently publishes guidance documents that help manufacturers navigate through the complexities of the regulation, click here to view them.
Miscellaneous
Click here to learn about various miscellaneous information pertaining to the EU in general, notified bodes and many other topics.
Other Legislation
Click here to learn more about other legislations including Personal Protective Equipment Regulation (PPER), Low-Voltage Directive (LVD) and Electro-Magnetic Compatibility Directive (EMC).
