Global Medtech Guidance Tracker: February 2023
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.
You may also be interested in...
FDA Updates Slew Of Radiology Guidance Documents
The US Food and Drug Administration has released revised versions of six guidance documents to reflect new x-ray reporting requirements, among other changes.
When Is An IVD A CDx? EU IVDR Guidance Updated To Include Flowchart
The EU Medical Device Coordination Group has issued a second revision to its guidance document on classification rules for in vitro diagnostics under the new regulation. The addition of a flowchart to determine when an IVD is a companion diagnostic is one key change.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.