In this expert webinar, MDSS explores the regulatory perspective on software and software-focused medical devices with insights from a Notified Body. ...
EUDAMED: The 60-Day Challenge
With the mandatory EUDAMED registration deadline approaching, manufacturers need to ensure that their device data and registration activities are read...
The role of the Importer under the MDR/IVDR — Myths, Misconceptions, and Real Obligations
This session addresses common myths regarding the Importer role under the MDR/IVDR, clarifying the regulatory requirements applicable to Importers and...
Team-NB Position Paper on the Transfer of IVDR Formal Applications and Surveillance of Legacy Devices
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...
