News

Jun 2, 2023

Mexico’s Ministry of Health Updated Regulation for Software as a Medical Device (Appendix X)

Mexico’s Ministry of Health has updated its regulation for software as a medical device (SaMD), known as Appendix X.

Stethoscope laying on a printed bar graph

Jun 2, 2023

Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Grouping

Mexico’s Ministry of Health has updated its requirements for medical device registration grouping.

US FDA rolls out notification requirements to protect medical device supply chains

Jun 2, 2023

Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Submissions

Mexico’s Ministry of Health has updated its requirements for medical device registration submissions.

Jun 2, 2023

Mexico’s Ministry of Health Updates Requirements for Medical Device Registration Renewals and Modification Submissions

Mexico’s Ministry of Health has updated its requirements for medical device registration renewals and modification submissions.

Brazil ANVISA provides new details on proposed UDI framework for medical devices

May 30, 2023

Brazil Moves Toward Leveraging Medical Device Registrations from Other Regulators

Brazil's ANVISA reports progress on establishing a route for recognizing registrations from "equivalent" medical device manufacturers

May 30, 2023

Update to European Guidance on Medical Device Significant Changes

Medical device manufacturers should assess any changes to their device design or intended purpose to determine if they are considered significant under newly updated EU regulatory guidance.

IVD Expert Panel now accepting submissions for performance evaluation consultations

May 26, 2023

Mexican Regulators Update Rules for IVD Medical Devices

Mexico's Ministry of Health revises classification requirements for in vitro diagnostic devices

May 26, 2023

New Confirmation Letter from European Commission on MDR Extensions

European Commission publishes new letter on Regulation (EU) 2023/607

May 22, 2023

Mexico Ministry of Health Updates Rules and Requirements for Medical Device Classification

A look at new and updated classification rules under the latest Supplement of Medical Devices of the Mexican Pharmacopoeia

May 17, 2023

Global Impact of (EU) Regulation 2023/607

Based on the glacial progress, delays with regulatory compliance, and paucity of notified bodies, (EU) Regulation 2023/607 was promulgated in mid-March to provide a longer transition timeline for manufacturers with legacy devices in the EU.

May 17, 2023

Webinar Debrief: Making the Most of Your Investment in Human Factors

Further analysis of "must-have" HFE capabilities versus the benefits of more extensive investments in human factors engineering resources for medical device companies

May 17, 2023

Wiklund's Perspective: HFE for Medical Devices

A look at how human factors engineering has evolved to become part of the medical device industry vocabulary

May 16, 2023

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Part 2 of our report on key human factors engineering themes at the 2023 HFES conference

May 14, 2023

Ongoing Collaboration Between Emergo by UL and the CMTC for Medical Device Usability Testing in China

Emergo by UL's Human Factors Research & Design team has been working with the Shanghai Center for Medical Testing and Inspection (CMTC) since 2020

May 14, 2023

Retroactive Interference in Training Decay Periods

How human factors engineering professionals can employ retroactive interference techniques to improve training outcomes

May 14, 2023

Understanding Different Users in Different Countries: Clinical Practice and Healthcare Systems

How medical device use and development are affected by differences in healthcare systems and clinical practices in different markets

May 12, 2023

European Regulators to Update Guidelines on Pthalates in Medical Devices

The European Commission seeks updated guidelines for benefit-risk assessments of devices containing pthalates

May 12, 2023

Revised Mexican Medical Device Legislation Includes Software as a Medical Device

Updated Pharmacopoeia expands Mexican regulatory definition of "medical device" to include SaMD

May 11, 2023

European Commission issues guidance on summary clinical investigation reports

The European Commission (EC) had been tasked with issuing guidance on the summary of the clinical investigation report (Article 77(6)).

May 1, 2023

UK MHRA Has Published Details on How to Manage Leveraging EU Compliance

UK regulators have issued new details regarding extended European Medical Devices Regulation (MDR) compliance timelines and how recognition of CE Marked devices will be affected in England, Scotland, Wales and Northern Ireland.

Mexico’s Ministry of Health Updated Regulation for Software as a Medical Device (Appendix X)

Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Grouping

Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Submissions

Mexico’s Ministry of Health Updates Requirements for Medical Device Registration Renewals and Modification Submissions

Brazil Moves Toward Leveraging Medical Device Registrations from Other Regulators

Update to European Guidance on Medical Device Significant Changes

Mexican Regulators Update Rules for IVD Medical Devices

New Confirmation Letter from European Commission on MDR Extensions

Mexico Ministry of Health Updates Rules and Requirements for Medical Device Classification

Global Impact of (EU) Regulation 2023/607

Webinar Debrief: Making the Most of Your Investment in Human Factors

Wiklund's Perspective: HFE for Medical Devices

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Ongoing Collaboration Between Emergo by UL and the CMTC for Medical Device Usability Testing in China

Retroactive Interference in Training Decay Periods

Understanding Different Users in Different Countries: Clinical Practice and Healthcare Systems

European Regulators to Update Guidelines on Pthalates in Medical Devices

Revised Mexican Medical Device Legislation Includes Software as a Medical Device

European Commission issues guidance on summary clinical investigation reports

UK MHRA Has Published Details on How to Manage Leveraging EU Compliance

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