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  • new
Unique Device Identifier (UDI) label
  • Regulatory Update
Jun 27, 2025

Current State of UDI in Brazil: Review of RDC 591/2021 and RDC 884/2024

Brazil’s medical device regulator, ANVISA, enacted RDC 591/2021, which legislated the Unique Device Identifier (UDI)...
  • new
AI and MI enabled medical devices
  • Regulatory Update
Jun 24, 2025

Decoding MDCG 2025-6: Interplay between the MDR/IVDR and AIA

The European Commission has released three new pieces of guidance on medical device software.
  • new
Equipment and glassware for test product extraction and orange color solution
  • Regulatory Update
Jun 23, 2025

EU Releases Guidance on IVD Performance Studies, Finally

The long-awaited Questions & Answers on In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Performance...
  • new
Picture of blood pressure monitor with a reading displayed.
  • Regulatory Update
Jun 20, 2025

European Revision of Primary Software Guidance (MDCG 2019-11 Revision 1): Small Changes, Meaningful Clarifications

Our regulatory experts clarify the implications of the European Commission’s revision to its guidance on primary...
  • new
Elderly person measuring their blood pressure
  • Regulatory Update
Jun 19, 2025

European Commission issues guidance on making safer apps available

The European Commission has published guidance on making safer apps available to patients and healthcare professionals.
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...
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...
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...
Person sitting at a desk taking an online webinar
  • 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...
  • new
Drawing of computer
  • 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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