New EU Rules on Substances of Human Origin (SoHO)
The European Union has introduced new standards to enhance the safety and quality of substances of human origin (SoHO), such…
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Swissmedic Issues Deadline for Legacy Device Compliance
Swissmedic informed Swiss Authorized Representatives and Regulatory Importers of their expectations regarding follow-up on the transitional provisions and obligations related…
Upcoming Deadline for MDR Conformity Assessment Agreements
As the September 26, 2024, deadline for MDR Conformity Assessment Agreements rapidly approaches, medical device manufacturers are reminded of the…
IMDRF Regulations Report: Harmonizing Medical Devices
The International Medical Device Regulators Forum (IMDRF) has today published its latest IMDRF Document Implementation Report. This…
MHRA IVD Clinical Investigations Guidance Update
The Medicines and Healthcare products Regulatory Agency (MHRA) has released an update to its guidance on clinical…
Predetermined Change Control Plans (PCCP) for Medical Devices
The FDA has recently issued a draft guidance for Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance,…
eMDR Enhancements: FDA Rolls Out Regular Updates
The FDA is now implementing enhancements to the Electronic Medical Device Reporting (eMDR) system on a regular schedule except for…
MHRA Quarterly Summary Report Template Update
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an important update that builds upon previous…
FDA Guidelines: Medical and In Vitro Diagnostic Device Classification
Classifying your medical device or in vitro diagnostic device (IVD) under the FDA is one of the first steps in…
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