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  • new
medical devices
  • Insights
Jun 13, 2025

Global Dates Format and Use of ISO Standard

Global date format differences can create challenges in labeling and data. This article explores how adopting ISO 8601-1...
  • new
HFE PMS 0623
  • Regulatory Update
Jun 13, 2025

The new Great Britain vigilance report schema goes live

On Monday, June 16, 2025, the new Great Britain vigilance report schema goes live in alignment with the timing of the...
  • new
Basilica Guadalupe Mexico City skyline
  • Regulatory Update
Jun 12, 2025

Mexican Regulator COFEPRIS Revises Equivalency Route to Expand Leveraging Options

To evaluate health supply registrations, Mexico’s COFEPRIS released a new agreement for the equivalency requirements...
Business executives meeting inside a modern wood paneled conference room
  • Regulatory Update
May 30, 2025

UK Medical Device Regulators Remove Revocation Dates for Assimilated EU Laws

Our regulatory experts update you on the MHRA publishing the UK Statutory Instrument No. 591, which is intended to...
graphic justification
  • Insights
May 29, 2025

Is Institutional Review Board (IRB) Approval Necessary for Usability Tests?

Learn when and why IRB approval is necessary for usability tests in medical device development, including regulatory...
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  • Regulatory Update
May 29, 2025

Search Functions in the European Medical Device Database EUDAMED

As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports...
FDA Logo on white background
  • Regulatory Update
May 28, 2025

FDA Expands 510(k) Premarket Notification Database to Include New Sub-Categories to Enhance Search Capabilities

The FDA has added six new subcategories to make it easier for users of the 510(k) Premarket Notification Database to...
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  • Regulatory Update
May 22, 2025

MHRA Publishes Guidance on Updated Schema for Incident and FSCA Reports in MORE

Great Britain’s medical device regulator unveiled new guidance outlining the implementation of new manufacturer...
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  • Regulatory Update
May 20, 2025

AI Literacy Per the European AI Act

As medical device manufacturers increasingly integrate AI technologies, the responsibility to confirm staff and end...
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  • Regulatory Update
May 19, 2025

Swissmedic releases new guidance and adopts the updated EU MIR form

Our regulatory experts bring you up to speed on the European Commission release of a new help text file with information...
FDA news picture 0923
  • Regulatory Update
May 8, 2025

FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot

The Office of Inspections and Investigations (OII), part of the U.S. FDA, will expand its program pilot of unannounced...
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  • Regulatory Update
May 5, 2025

European Commission Releases New Manufacturer Incident Report Form and Help Text

Read our regulatory experts’ timely summary of this latest medical device regulatory development from the European...
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