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591 results
  • new
Blood pressure monitors and drug test kits on display
  • Regulatory Update
Jul 14, 2025

A Shift in the Compliance Landscape: The EU GPAI Code of Practice is Here

New AI-driven healthcare devices placed on the European market must comply with the General-Purpose AI Code of Practice...
  • new
London Bridge at dusk
  • Regulatory Update
Jul 10, 2025

UK MHRA Publishes Common Specification Requirements for IVD Devices

Keep up with IVD regulations in the UK. See our analysis of the outcome of the UK medical device regulator’s...
  • new
Reading IFUs
  • Insights
Jul 7, 2025

5 Methods for Evaluating Your Instructions for Use: Benefits and Drawbacks

We provide five methods to evaluate instructions for use.
Two people in a dark office reviewing data on a computer
  • Regulatory Update
Jul 7, 2025

FDA Releases Final Guidance on Medical Device Cybersecurity

We explain the requirements of recent FDA cybersecurity guidance.
  • new
Secure data management to meet HIPAA, PHI, and requirements of Covered Entities or Business Associates.
  • Insights
Jul 3, 2025

Is it Too Bold to Refer to this as the Quarter of Data Accessibility?: Second Quarter 2025 Developments

Follow our coverage of medical device regulatory news with this examination of developments from the second quarter of...
Medical device sketch page
  • Regulatory Update
Jul 2, 2025

European Packaging Waste Legislation Repeals the Directive and Applies in Mid-2026

European medical device Regulation (EU) 2025/40 governing packaging waste was published in January 2025, and most of the...
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)...
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.
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...
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...
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.
  • new
Icon of a date circled on a calendar
  • 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...
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