MHRA Opens Public Consultation on Proposed Changes to Medical Device Regulatory Framework
U.K. MHRA invites members of the public to provide their views on proposals to update four areas of the legislation for medical devices in Great Britain.
MEDICA 2024 | Big data is coming and we’re going to be monitored
Emergo by UL attended MEDICA 2024. It is always a great opportunity for those in the healthcare field to descend upon Messe Dusseldorf.
MDCG Vigilance Guidance Updated to Include IVDs
The Medical Device Coordination Group (MDCG) has issued an update to the European vigilance guidance MDCG 2023-3.
Optimization for Global Vigilance Reporting
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on optimization for global vigilance reporting.
Supporting ANVISA: A Commitment to Innovation and Health in Brazil
In Brazil, Class III and IVD medical devices are submitted as a registro to the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária). In addition, substantial modifications to registros need to be reported.
Global Unique Device Identification for Medical Devices
This whitepaper outlines global UDI regulations, the FDA’s role in adoption, and resources for medical device companies navigating regulatory compliance.
MHRA Update on the U.K. MedTech Roadmap
The Medicines and Healthcare products Regulatory Agency (MHRA) has published further updates on its emerging roadmap, which offers significant new opportunities for new technologies, patients and healthcare in the U.K.
EU Update: New MDCG Guidance Document 10a
Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents.
Great Britain's Draft Post-market Surveillance Requirements Compared to EU Requirements on Vigilance
Emergo by UL examines proposed post-market surveillance and vigilance requirements in the U.K. versus Europe in the last of our three-part series.
Medical Device and IVD Registration in the UK
Stay informed on post-Brexit medical device regulations, including compliance changes and protocols impacting trade for manufacturers and distributors.