Emergo by UL News

Mar 20, 2023

Amendment addressing extension of the MDR transitional periods and abandoning “sell-off” provisions goes into effect

The amendment addressing the extension of the MDR transitional periods and abandoning the “sell-off” provisions has gone into force.

Mar 16, 2023

How Can We Define Successful Task Completion Within a Usability Test?

Suggestions for defining task completion and measuring completion rates in medical device usability testing

Mar 14, 2023

The European MDR Amendment: What to expect and When?

Key questions and answers on new amendment extending European MDR transition period

US FDA medical device user fees see modest increase for 2022

Mar 10, 2023

US FDA Roundup: Revised EUA for Surgical Masks; Extended MDSAP Temporary Audit Measures and More

The US FDA has issued a number of updates, including revised emergency use authorizations (EUA) for surgical masks, extended MDSAP temporary audit measures, and more.

Vietnamese Ministry of Health proposes new decree for medical device regulation

Mar 10, 2023

Vietnamese Regulators Amend Medical Device Registration Requirements

Vietnam Ministry of Health extends transition periods for higher-risk medical devices

Mar 10, 2023

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

How human factors engineering and usability practices can impact life sciences beyond medical devices

Mar 9, 2023

European Regulators Move to Increase Notified Body Capacity

Two Delegated Regulations from the European Commission will decrease frequency of Notified Body re-assessments under MDR, IVDR

New Brazil INMETRO ordinance eases inspection and documentation requirements

Mar 7, 2023

Brazil Market Update: Amendments to RDC No. 751/2022 on Medical Device Registration and Notification

Brazil’s national health surveillance agency, ANVISA has published RDC No. 777/2023.

Phased implementation timeframes for European IVDR compliance

Mar 7, 2023

Unanimous European Council Vote to Extend MDR Transition Periods

European Council vote means longer MDR transition timelines for qualifying medical devices

Feb 28, 2023

ICPHSO 2023 Report: Michael Wiklund Discusses Key Human Factors Engineering Issues

Wiklund covers HFE, risk analysis and user risk mitigation at ICPHSO 2023 Annual Meeting

NMPA publishes revised Chinese medical device regulations

Feb 24, 2023

Chinese Regulators Publish Timelines for Medical Device Supplementary Information and 2022 Medical Device Standards

Chinese Regulators Publish Timelines for Medical Device Supplementary Information and 2022 Medical Device Standards Management Report

Feb 24, 2023

European Update: Is an EU MDR Article 59 Derogation a Way to Continue to Market?

Is an EU MDR Article 59 Derogation a Way to Continue to Market?

Feb 24, 2023

US FDA Annual Report: Nearly 6,000 Medical Device Authorizations in 2022

FDA annual report shows depth and breadth of Center for Devices and Radiological Health (CDRH) medical device activities through 2022

Feb 22, 2023

Expectations for Post-Market Surveillance (PMS) in the European MDR

What’s the status of your EU MDR Article 86 Periodic Safety Update Report (PSUR)? Class IIa legacy devices are approaching the deadline of their first PSUR, whereas Class III and IIb legacy devices should already have their first PSUR issued.

Feb 17, 2023

European Parliament Votes in Favor of Amendment Extending MDR, IVDR Timelines

Amendment to extend European MDR, IVDR transition timelines clears key vote

Feb 17, 2023

New European MDCG Guidance on Medical Device Vigilance Requirements

MDCG clarifies vigilance reporting requirements under the EU Medical Devices Regulation (MDR)

Feb 16, 2023

Brazil Update: Does RDC 751/2022 Change Labeling Requirements?

A look at what has changed between RDC 185/2001 and RDC 751/2022 in terms of medical device labeling requirements

Feb 14, 2023

Report from the 7th European Association of Authorised Representatives Annual Conference

Emergo by UL takeaways from the EAAR conference regarding European MDR, IVDR implementation and compliance

Feb 13, 2023

The HFR&D Process for Conducting Root Cause Analysis

Our Human Factors Research & Design (HFR&D) team's seven-step process for analysis of root causes of medical device use-related issues

Feb 8, 2023

HFR&D Webinar Debrief: December 2022 Draft US FDA Guidance on HFE for Medical Devices

Key questions from HFR&D webinar attendees on new US FDA human factors engineering guidance for medical devices

News

Get the latest global medical device regulatory news, insights from our experts, and more.

Amendment addressing extension of the MDR transitional periods and abandoning “sell-off” provisions goes into effect

How Can We Define Successful Task Completion Within a Usability Test?

The European MDR Amendment: What to expect and When?

US FDA Roundup: Revised EUA for Surgical Masks; Extended MDSAP Temporary Audit Measures and More

Vietnamese Regulators Amend Medical Device Registration Requirements

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

European Regulators Move to Increase Notified Body Capacity

Brazil Market Update: Amendments to RDC No. 751/2022 on Medical Device Registration and Notification

Unanimous European Council Vote to Extend MDR Transition Periods

ICPHSO 2023 Report: Michael Wiklund Discusses Key Human Factors Engineering Issues

Chinese Regulators Publish Timelines for Medical Device Supplementary Information and 2022 Medical Device Standards

European Update: Is an EU MDR Article 59 Derogation a Way to Continue to Market?

US FDA Annual Report: Nearly 6,000 Medical Device Authorizations in 2022

Expectations for Post-Market Surveillance (PMS) in the European MDR

European Parliament Votes in Favor of Amendment Extending MDR, IVDR Timelines

New European MDCG Guidance on Medical Device Vigilance Requirements

Brazil Update: Does RDC 751/2022 Change Labeling Requirements?

Report from the 7th European Association of Authorised Representatives Annual Conference

The HFR&D Process for Conducting Root Cause Analysis

HFR&D Webinar Debrief: December 2022 Draft US FDA Guidance on HFE for Medical Devices