New US FDA Guidance Provides Content Recommendations for Medical Device Software Premarket Submissions
The US Food and Drug Administration has published new draft guidance recommending documentation to include in premarket submissions for medical devices that use software.
European Commission Publishes IVDR Joint Implementation Plan
EC maintains May 2022 date of application for IVDR despite calls for delay
US FDA Extends UDI Deadlines for Low-risk Medical Devices
FDA focusing on coronavirus pandemic response, UDI implementation for higher-risk medical devices. Learn more about Unique Device Identification regulations at Emergo by UL.
Eudamed Requirements Ahead of Eudamed
Eudamed is one of the key drivers of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR).
New Taiwanese Medical Device Regulations Set for May 2021
Taiwan Medical Devices Act will establish new regulatory framework for medical device market access. Learn more at Emergo by UL.
US FDA Roundup: Final De Novo Rule, GUDID for Class I Medical Devices, Reclassification of Surgical Staples
US regulators have issued final rules for de novo novel device classification requests and up-classification of surgical staplers, as well as updated GUDID submission requirements for some class I devices. Learn more at Emergo by UL.
UK Passes Post-Brexit Medical Device Regulatory Bill into Law
The UK Parliament passed the Medicines and Medical Devices Act 2021, providing the foundation for the country's post-Brexit regulatory system for healthcare products.
Australia TGA to Accept CE Mark Conformity Assessments for Some High-Risk Medical Devices, IVDs
The therapeutic goods administration (TGA) will accept conformity assessments from European notified bodies for some Class III medical devices, active implantable devices and Class 4 IVDs submitted for registration in Australia. Learn more at Emergo by UL
IVDR Watch: European Regulators Update Implementation Framework
Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022.
Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions
New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater powers for regulatory authorities relating to post-market surveillance and risk management.