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US FDA medical device user fees see modest increase for 2022

Dec 16, 2022

Applying the US FDA's New Human Factors Engineering Guidance for Medical Device Submissions

Our Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices

Dec 15, 2022

IVDR Update: European MDCG Issues Guidance on Substantial Modification of a Performance Study

An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.

Usability lab clinical product observation room HFRD

Dec 14, 2022

Creating a Realistic Simulated Medical Environment

Recommendations for creating realistic medical device and healthcare product test environments

Important considerations for conducting in-home research

Dec 14, 2022

Reflecting on 2022

Our Human Factors Research & Design leader looks back on the year that was

Dec 14, 2022

The Future of Healthcare in the Metaverse

A look at how the metaverse may affect healthcare delivery and medical product development

Dec 14, 2022

Wiklund's Perspective: New Technology Creates New Barriers

Innovative technologies and the need for inclusivity

Dec 13, 2022

European MDCG Clarifies Market Access Requirements for Legacy Devices Under Article 97 MDR

An MDCG position paper explains the process for obtaining permission to sell legacy devices in European Union member states according to Article 97(1) MDR

20th Notified Body designated under EU MDR while IVDR designations lag

Dec 8, 2022

European Commission Proposes Extending MDR, IVDR Transition Periods

European regulators have put forth amendments to MDR, IVDR compliance timelines to avoid medical device and IVD supply disruptions

Japan PMD Act revisions include fast-track reviews for some medical devices and IVDs

Dec 8, 2022

Japan’s MHLW Updates Medical Device Program Display Code and Labeling Laws

Japanese medical device regulators have updated program codes and labeling rules.

Dec 8, 2022

New US FDA Guidance on Human Factors Engineering for Medical Devices

US regulators lay out recommendations for HFE information to include in medical device registration applications

US FDA formally proposes aligning Quality System Regulations with ISO 13485

Dec 6, 2022

FDA Asks COVID Test Makers to Switch from Emergency to Premarket Approvals

The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.

Dec 6, 2022

FDA Launches TAP Pilot to Speed Access to Safe and Innovative Medical Devices

The US FDA announced that it has launched a pilot program designed to help medical device premarket reviews become more efficient.

Dec 6, 2022

UK Regulator MHRA to Raise Medical Device Registration and Other Fees by 10% or More

The UK’s MHRA invited public comment regarding its proposed fee increases.

Dec 6, 2022

US FDA Issues Roadmap to Medical Device Regulatory Guidance Topics List for 2023

The US FDA released a list of guidances it plans to issue over its 2023 fiscal year.

Dec 5, 2022

Common Use-related Risk Analysis Pitfalls

A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process that is expected by regulators.

Dec 5, 2022

European Notified Body Survey: MDR, IVDR Certification Numbers Remain Low

A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).

Dec 5, 2022

Health Canada Issues Final Guidance on Clinical Evidence Requirements for Medical Devices

Health Canada finalized guidance on clinical evidence requirements for medical devices.

Dec 5, 2022

Health Canada Reminds EHR-based Medical Device Manufacturers of Regulatory Rules

Health Canada reminded manufacturers of EHR-based medical devices to obtain a medical device license and/or establishment license.

Dec 5, 2022

Malaysia MDA Publishes Draft Guidance on Notification of Custom-made Medical Devices

Malaysia’s MDA published draft guidance that provides a notification process for manufacturers of custom-made medical products when seeking Malaysian market access.

Dec 5, 2022

MDCG Issues New Guidance on MDR, IVDR Authorized Representative Requirements

Europe’s Medical Device Coordination Group (MDCG) has issued guidance on the responsibilities of authorized representatives.

News

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

Applying the US FDA's New Human Factors Engineering Guidance for Medical Device Submissions

IVDR Update: European MDCG Issues Guidance on Substantial Modification of a Performance Study

Creating a Realistic Simulated Medical Environment

Reflecting on 2022

The Future of Healthcare in the Metaverse

Wiklund's Perspective: New Technology Creates New Barriers

European MDCG Clarifies Market Access Requirements for Legacy Devices Under Article 97 MDR

European Commission Proposes Extending MDR, IVDR Transition Periods

Japan’s MHLW Updates Medical Device Program Display Code and Labeling Laws

New US FDA Guidance on Human Factors Engineering for Medical Devices

FDA Asks COVID Test Makers to Switch from Emergency to Premarket Approvals

FDA Launches TAP Pilot to Speed Access to Safe and Innovative Medical Devices

UK Regulator MHRA to Raise Medical Device Registration and Other Fees by 10% or More

US FDA Issues Roadmap to Medical Device Regulatory Guidance Topics List for 2023

Common Use-related Risk Analysis Pitfalls

European Notified Body Survey: MDR, IVDR Certification Numbers Remain Low

Health Canada Issues Final Guidance on Clinical Evidence Requirements for Medical Devices

Health Canada Reminds EHR-based Medical Device Manufacturers of Regulatory Rules

Malaysia MDA Publishes Draft Guidance on Notification of Custom-made Medical Devices

MDCG Issues New Guidance on MDR, IVDR Authorized Representative Requirements