• 2025-01-22 07:00:59

This guidance provides instructions for sponsors on submitting clinical investigation reports and their summaries to Member States' competent authorities when EUDAMED is not fully functional.

• 2024-06-20 05:24:57

This guidance outlines the requirements for sponsors submitting applications for clinical investigations and supports sponsors in developing the Investigator's Brochure.

• 2024-05-08 02:32:34

This guidance provides detailed instructions to assist sponsors in preparing plans that fulfill regulatory expectations and streamline the assessment process by competent authorities.

• 2024-03-01 08:34:44

This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices

• 2023-06-28 09:38:06

This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.