MDCG 2025-5: New IVDR Guidance on IVD Performance Studies
The Medical Device Coordination Group (MDCG) has published MDCG 2025-5 “Questions & Answers regarding performance studies…
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New UK PMS Update to the Medical Devices Regulations 2024
The passing of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which amends…
New FDA Guidance on 510(k) Transfer for Medical Devices
A New FDA 510(k) transfer draft outlines key steps for medical device companies.
Updated Guidance on the FDA Q-Submission (Q-Sub) Program
Discover the latest FDA Q-Submission Guidance to improve medical device submissions, gain early feedback, and streamline your FDA regulatory strategy.
New Form for Reporting Serious Incidents Now Also Applicable to Switzerland
Learn about the updated Manufacturer Incident Report (MIR) requirements for reporting medical device incidents in Switzerland.
New EU MedTech Regulatory Reform for Medical Technologies
EU MedTech considers regulatory reform changes to maintain Europe's status as a global leader in medical technologies.
New EU Revised Manufacturer Incident Reporting Form
Discover the latest updates in EU Manufacturer Incident Report (MIR) Version 7.3.1.
Two New Notified Bodies Added Under the IVDR (EU 2017/746)
Two new Notified Bodies have been added under the IVDR...
Team NB Position Paper: IVDR Certification Process
Team NB IVDR certification guidance outlines pre-application and application procedures for IVDs.
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