Leveraging Other Medical Device Regulatory Authorizations for New Market Access
Has it become vogue to leverage other regulators’ authorizations for medical device market access?
Meeting EUDAMED Requirements
Learn about the European Database on Medical Devices (EUDAMED) compliance requirements for medical device and in-vitro diagnostics (IVD) companies in Europe.
US FDA Transitions COVID-19 Guidance Documents for the End of Public Health Emergency
The US FDA issued a notice identifying how the agency plans to transition the guidance documents related to COVID-19 once the public health emergency (PHE) ends.
Guidance on European MDR Extension, MDR and IVDR Sell-off Period Deletion
European Commissioners have published a new Q&A resource document covering recent amendments to European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements.
Amendment addressing extension of the MDR transitional periods and abandoning “sell-off” provisions goes into effect
The amendment addressing the extension of the MDR transitional periods and abandoning the “sell-off” provisions has gone into force.
The European MDR Amendment: What to expect and When?
Key questions and answers on new amendment extending European MDR transition period
Vietnamese Regulators Amend Medical Device Registration Requirements
Vietnam Ministry of Health extends transition periods for higher-risk medical devices
US FDA Roundup: Revised EUA for Surgical Masks; Extended MDSAP Temporary Audit Measures and More
The US FDA has issued a number of updates, including revised emergency use authorizations (EUA) for surgical masks, extended MDSAP temporary audit measures, and more.
European Regulators Move to Increase Notified Body Capacity
Two Delegated Regulations from the European Commission will decrease frequency of Notified Body re-assessments under MDR, IVDR
Unanimous European Council Vote to Extend MDR Transition Periods
European Council vote means longer MDR transition timelines for qualifying medical devices