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  • Regulatory Update
May 20, 2024

The European Artificial Intelligence Act: Key Elements and Best Practices

Medical device makers will want to read the second story in our series covering the implications of the EU Artificial Intelligence Act.
Doctors discussing an X-Ray
  • Regulatory Update
May 13, 2024

EU Update: Medical Device Regulator MDCG Releases New Guidance on Safety Reporting for IVD Clinical Performance Studies

In April, the MDCG released new guidance regulating IVDs in Europe. It examines safety reporting requirements for IVD performance studies under the IVDR.

EU flag waving in front of a building
  • Regulatory Update
May 10, 2024

The European Artificial Intelligence Act: Impact for Medical Devices

Emergo by UL examines the European AI Act and its effects on medical device and IVD regulatory compliance
Girl monitoring medical device patch with smartphone
  • Regulatory Update
May 8, 2024

Mexico COFEPRIS Announces Revised Labeling Standard

This is our fourth update on the recently released draft standard published by Mexico’s medical device regulator COFEPRIS for medical device labeling, NOM-137-SSA1-2024.

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  • Insights
May 7, 2024

2024 MedCon Takeaways: Quality system and post-market considerations

Highlights from the 2024 MedCon Conference include preparations for the transition to the Quality Management System Regulation (QMSR), Medical Device Single Audit Program (MDSAP) updates and U.S. FDA inspection best practices
AI and MI enabled medical devices
  • Insights
May 7, 2024

FDA Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices

Guidance for manufacturers developing ML-DSF-enabled devices to rapidly iterate, develop and improve under the highly adaptive nature of AI and ML.
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  • Regulatory Update
May 7, 2024

Mexico COFEPRIS Announces Revised Draft Labeling Standard

This is the third installment in our series regarding Mexico’s medical device regulator COFEPRIS announcement of its revised draft labeling standard.
Validation testing reports
  • Insights
May 6, 2024

Determining When It’s Possible to Forgo HF Validation Testing

HF validation testing may not be necessary for medical and drug delivery devices. Learn from Emergo by UL's insights on navigating FDA regulations and developing sufficient justifications.
Clinical data and post-market compliance under the MDR
  • Regulatory Update
May 6, 2024

U.S. FDA Final Rule Published on Laboratory Developed Tests (LDTs)

The U.S. FDA published the text of the Final Rule for Laboratory Developed Tests (LDTs) May 6.



Combination medical devices
  • Insights
May 3, 2024

Similar but different: the importance of combination product differentiation

Emergo by UL's Human Factors Specialists share key considerations for combination product differentiation.
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  • Insights
May 1, 2024

2024 MedCon Takeaways: Pre-Market Considerations

Here we describe our top pre-market consideration takeaways from the MedCon Conference in Columbus, Ohio on April 24-26 for those who were unable to attend.
Mother helping son use medical device
  • Regulatory Update
Apr 30, 2024

Mexico COFEPRIS Announces Revised Draft Labeling Standard

The medical device regulator in Mexico, COFEPRIS, recently released a new project for the NOM for Medical Device labeling, NOM-137-SSA1-2024 that is open for industry comment.
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