The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Clinical Investigations



Document Type:
The primary purpose of this document is to provide guidance in relation to when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles and the general principles of clinical investigation involving medical devices.

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GMP Conferences by Topics

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