Global Medtech Guidance Tracker: May 2023
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.
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EC Guidance Document Details Notification Process For Clinical Investigation Reports
The Medical Device Regulation requires sponsors of clinical investigations to file a summary of their report shortly after study completion. The commission explains the steps and the need for conciseness.
Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare
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EU Group Facilitates Switching Multinational Trials To CTR
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”