European Commission issues guidance on summary clinical investigation reports
The European Commission (EC) had been tasked with issuing guidance on the summary of the clinical investigation report (Article 77(6)).
Medical Device Registration - Mexico Updates
In this complimentary webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes.
UK MHRA Has Published Details on How to Manage Leveraging EU Compliance
UK regulators have issued new details regarding extended European Medical Devices Regulation (MDR) compliance timelines and how recognition of CE Marked devices will be affected in England, Scotland, Wales and Northern Ireland.
Software as a Medical Device (SaMD): EU/US Regulatory Considerations
In this webinar, we provide information on considerations for designing and classifying SaMD in the United States and European Union.
Clinical Data in Support of U.S. FDA 510(k) Submissions
Read this white paper to learn about FDA requirements for clinical evidence.
Japan Market Update: Guidelines and Q&A on Remanufactured Single-Use Medical Devices, Software as a Medical Device
Japan’s Ministry of Health, Labour and Welfare (MHLW) has published several updates regarding medical device registration and compliance. The releases include guidelines and questions and answers on remanufactured single-use medical devices and more.
European Countries that Require CE Marking
The European Union comprises 28 countries that require CE Marking. Emergo by UL can assist you in obtaining CE Marking so you can sell your medical device in any of these European countries.
Software as a Medical Device (SaMD) (Presented in French)
Regardez maintenant : le logiciel en tant que dispositif médical (SaMD) : considérations réglementaires UE/USA
Preparing for IVDR Certification
In this webinar, our Emergo by UL subject matter expert outlines the latest updates about preparing for IVDR certification regulation updates.
Leveraging Other Medical Device Regulatory Authorizations for New Market Access
Has it become vogue to leverage other regulators’ authorizations for medical device market access?