Emergo by UL News

Mar 29, 2023

UK Medical Device Regulators to Accept Extended EU Certificates

The UK MHRA will recognize extended CE Mark certifications recently announced in Europe

UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates

Mar 29, 2023

Update from UK Life Sciences Council on Advisory Group Reform Proposals

UK advisory group to develop medical device regulatory reforms

Mar 27, 2023

Guidance on European MDR Extension, MDR and IVDR Sell-off Period Deletion

European Commissioners have published a new Q&A resource document covering recent amendments to European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements.

US FDA formally proposes aligning Quality System Regulations with ISO 13485

Mar 27, 2023

US FDA Transitions COVID-19 Guidance Documents for the End of Public Health Emergency

The US FDA issued a notice identifying how the agency plans to transition the guidance documents related to COVID-19 once the public health emergency (PHE) ends.

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)

News

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

UK Medical Device Regulators to Accept Extended EU Certificates

Update from UK Life Sciences Council on Advisory Group Reform Proposals

Guidance on European MDR Extension, MDR and IVDR Sell-off Period Deletion

US FDA Transitions COVID-19 Guidance Documents for the End of Public Health Emergency

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