In-house Tests Under EU IVDR – How to Best Meet Your IVDR Deadlines
In this on-demand webinar, our Emergo by UL subject matter expert navigates through current regulatory requirements under IVDR.
FDA Sounds Alarm on Fraudulent Testing Data at Third-party Labs
The FDA reminds device manufacturers and medical device study sponsors to cautiously select third-party laboratories for verification and validation testing.
New Medical Device Usability Engineering Standard from MHLW
The new JIS T62366-1:2022 standard comes with updated requirements on usability engineering for medical devices.
US FDA CDRH Warning Letters: A Review of 2023
Manufacturers can better understand quality and regulatory issues of concern by the U.S. Food and Drug Administration (FDA) by reviewing relevant warning letters. This can allow companies to focus on problem areas as they continually assess and improve their internal procedures and processes.
Frequent European Issues identified in customs or by competent authorities
We at Emergo by UL have seen an increase in labeling issues since the Date of Application (DoA) for the Regulations, Medical Device Regulation (2017/745, MDR) and In Vitro Diagnostic Device Regulation (2017/746, IVDR). The issues are identified during customs review which delays shipments of medical devices to intended recipients.
Developing HFE Strategies to Meet Global Regulations
Understand key global regulators’ HFE expectations, and what HFE activities to perform and deliverables to prepare, to meet those expectations.
Brazil ANVISA Announces Priorities for the 2024-2025 Year
Brazil’s medical device market regulator, ANVISA, announced its priorities in the “Regulatory Agenda” for the 2024-2025 year.
The European Proposal to Delay Compliance for Legacy IVDs and EUDAMED Rollout
The EC proposed a delay to compliance of legacy IVDs and for EUDAMED to be phased in.
Switzerland Update: Swissmedic Medical Device Database Release Delay
Medical device regulator Swissmedic updated the release schedule for the swissdamed database.
U.S. FDA IVD Reclassification Announcement for Laboratory Developed Tests
In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a specific type of premarket submission type, based on risk.