Conducting HFE Activities to Meet Global Human Factors Engineering Requirements
Human Factors Engineering (HFE) requirements for medical devices vary across different countries and regions. As a result, medical device manufacturers face the challenge of meeting multiple sets of requirements to market their products in different countries.
European Proposal to Delay Compliance for Legacy IVDs and Roll-out EUDAMED
European Commission seeks delay of IVDR compliance for legacy devices and faster implementation of EUDAMED modules
MDCG Updates Joint Implementation Plan for European IVDR
IVD manufacturers doing business in Europe will want to review regulators’ current list of priorities to maintain market access.
Regulation EU 2023/607 Frequently Found Issues
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about Regulation EU 2023/607.
EU Update: Overview of European Language Requirements for Medical Devices
The European Commission recently published two tables on its website to help manufacturers understand national language requirements under the MDR and IVDR.
EU Update: New Data Dashboard on Medical Device Availability
The EC has rolled out a new data dashboard to provide more transparency in medical device availability across European Union member states.
UK Update: Start of the New Year and MHRA Announces Road Map
The medical device regulator for the UK, the MHRA, has posted the 2024-2025 UK regulatory roadmap to illustrate its plans for the year.
EU Update: New Guidance on Exemptions to Clinical Investigations for High-Risk Medical Devices
Medical device makers in the EU will want to take note of new guidance regarding exemptions to clinical investigation requirements for high-risk medical devices.
Israel Update: Declaration Route for Low-Risk Medical Devices Now in Effect
The Israeli Medical Devices Agency (AMAR) has implemented revised registration requirements for some Class I medical devices and IVDs
Methods for Identifying Potential Use Errors
Webinar Debrief: Methods for Identifying Potential Use Errors