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Writing Clinical Evaluations for Medical Devices

Level:
Advanced
Area:
Drug Development
Code:
DDA21
Duration:
03:30:00
Workshop profile:
Medical writers with experience in regulatory writing. Experience and understanding of the regulatory requirements for the market approval of medicinal products is expected. Participants should know how medical devices are classified or have participated in the workshop “Introduction to Writing for Medical Devices”.
Objective:
To provide insight into the Clinical Evaluation of Medical Devices, which is an essential requirement for introducing a new medical device to the European market and is also a “vigilance” document which has to be updated regularly.
Content:
Focusing on medium and high risk medical devices, the workshop will introduce: • The Technical or Design Dossier (equivalent to the CTD for medicinal products) • The Clinical Evaluation and its role in the market approval process • The “literature” based Clinical Evaluation (when it can be used and how to write it) • The Clinical Investigation and the Clinical Investigation Plan for high risk devices, including when it is necessary to run a clinical investigation with a new medical device. • The most common sources for the scientific and vigilance data required for a Clinical Evaluation. The workshop will include group exercises and discussions as well as evaluations of real documents.