Thirty-five guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’sGuidance Tracker in the past month.
The updated tracker includes several new guidelines from different jurisdictions on the clinical investigation of medical devices. The EU’s Medical Device Coordination Group, for example, has issued a new document on the content of the Investigator’s Brochure, which complements its earlier guide on the content of device clinical investigation plans
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