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Regulatory Updates

Stay current with the most recent regulatory updates.

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Get the latest global medical device regulatory news from our experts.

Latest insights on FDA expectations from the 2020 Virtual HFES Health Care Symposium
  • Regulatory Update
May 29, 2020

Latest Insights on FDA Expectations from the 2020 Virtual HFES Health Care Symposium

FDA recognizes the constraints that COVID-19 has placed on in-person testing, but emphasized the importance of seeking
The European MDR and human factors engineering: Intended purpose
  • Regulatory Update
Mar 25, 2020

The European MDR and Human Factors Engineering: Intended Purpose

In the second blog post in our series on human factors engineering and the European Medical Devices Regulation (MDR), we will discuss intended purpose:
European Union
  • Regulatory Update
Mar 4, 2020

The European MDR and Human Factors Engineering: Introduction

Emergo by UL's Human Factors Research & Design (HFR&D) experts examine how Europe's MDR affects HFE and usability requirements for medical device manufacturers.

Japan at sunset
  • Regulatory Update
Feb 10, 2020

Japanese Regulatory Ministry Publishes Guidance on Biocompatibility Testing to Updated Standard

The Ministry of health, labour and welfare (MHLW) has published notification No. 0106-1, requiring manufacturers to test in accordance with JIS T 0993-1:2020.
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  • Regulatory Update
Jan 7, 2020

New Guidance Published for Medical Device and IVD Cybersecurity Under MDR and IVDR in Europe

European MDCG establishes medical device and IVD cybersecurity framework based on IMDRF recommendations. Learn more about medical device cybersecurity issues at Emergo by UL.