IVDR Transition Deadline What Happens After May 26, 2025
Prepare for the IVDR Transition Deadline on May 26, 2025. Learn what legacy IVD manufacturers must do to maintain EU market access.
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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.
Economic Operators Under the MDR and IVDR
This webinar breaks down the roles and responsibilities of economic operators under the MDR and IVDR.
MDR QMS Notified Body Assessment
Webinar: MDR QMS Notified Body Assessment
Understanding MDR and IVDR Post Market Surveillance
Explore key elements of Post Market Surveillance (PMS) under MDR and IVDR in our latest webinar.
Technovigilance: PMS Reporting Requirements in Mexico
Learn about technovigilance requirements in Mexico for medical devices, including COFEPRIS compliance, adverse event reporting, and more.
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...
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