MHRA Expands Regulatory Advice Access for Manufacturers
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated and expanded its regulatory advice service for medical devices…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 19–27 of 624
EUDAMED and swissdamed Mandatory Registration Requirements
Mandatory registration in EUDAMED and swissdamed is finally here. By 28 May 2026, manufacturers marketing medical devices and IVDs in the EU must have completed their EUDAMED…
FDA Issues Technical Amendments to Align with QMSR
The U.S. Food and Drug Administration (FDA) has published a final rule implementing technical amendments across…
EU Confirms EUDAMED Functionality and 2026 Deadline
The European Commission has officially confirmed that several key electronic systems within the European Database on Medical Devices (EUDAMED) are…
FDA Regulatory Inspections and Audits
Preparing for regulatory authority (e.g. US FDA) inspections and Notified Body audits (for CE Marking) is a critical, ongoing process…
MDCG 2025-8 and the New Master UDI-DI Requirements
The Medical Device Coordination Group (MDCG) has published MDCG 2025-8, a comprehensive guidance document on the…
The EU AI Act and Notified Bodies
As highlighted earlier this year, Team-NB published an updated version of their Position Paper on “European Artificial Intelligence Act (AI ACT)”, it highlights…
New Team-NB Update on Companion Diagnostics Under the IVDR
Team-NB has released a guidance paper on Companion Diagnostics (CDx), providing clarity on how to interpret significant changes to CDx…
New UK CE Certificate Rules for ARTG Inclusion Applications
The TGA has released the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, introducing new provisions regarding…
Showing 19–27 of 624