Clinical Evaluation for EU Market Approval: Process and Regulatory background
Manufacturers planning to market their devices in Europe are required to furnish clinical data in line with the European Directives.
This course provides professionals with an expert overview of the EU regulations and how they can positively impact global market access as well as a detailed outline of the necessary steps to follow to achieve immediate and lasting compliance of their clinical evaluation.
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Upon completion of this course, trainees will be able to correctly and successfully:
- Distinguish the different methods to obtain clinical data for EU market access and understand how the conduct of a critical review of existing data lays the basis for a decision to embark upon a prospective clinical investigation or not.
Senior clinical managers, Director Clinical Research, VP Clinical Research, Medical Writer, Senior Regulatory managers, Director Regulatory affairs, VP regulatory affairs involved in the strategic planning of clinical evaluations for EU and Global market access of a medical device.
Understand the requirements of the Directives 93/42/EEC, 90/385/EEC, as outlined in the course on the European Union Regulatory System for Medical Devices (ID 145) ISO 14155:2011 as outlined in either ISO 14155:2011 an in depth review (ID 68) or ISO 14155 a summary review (ID 144).