On 10 June 2026, the European Association of Medical Devices Notified Bodies (Team-NB) adopted a new Position Paper entitled: “Agreement Related...
MHRA Updates Guidance on Modifications to Clinical Trial Approvals
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance “Clinical Trials for Medicines: Modifying a Cl...
FDA Updates Guidance on Exemptions for Certain Unclassified Medical Devices from Premarket Notification Requirements
The U.S. Food and Drug Administration (FDA) has issued an updated guidance document, “Intent to Exempt Certain Unclassified Medical Devic...
EUDAMED Release notes
Production 2.27.0 – 2026 Download...
