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

European Union
  • Regulatory Update
Feb 16, 2021

How Legacy Medical Devices and IVDs Will be Managed in Europe’s Eudamed Database

Unique device identifier assignments and guidelines for legacy devices whose CE Marking will remain valid after MDR, IVDR come fully into force
Flag of Norway
  • Regulatory Update
Feb 14, 2021

Norwegian Language Requirement Will Apply Following MDR Implementation

The Norwegian medicines agency (NoMA) has confirmed that, in order to be marketed in Norway, medical devices must include labeling and instructions for use (IFUs) in the Norwegian language.
Drawing of 2 people talking
  • Insights
Feb 11, 2021

Introducing High Schoolers to Human Factors Engineering and Usability

Emergo by UL's Human Factors Research & Design team expanding awareness of human factors and usability.
Five design tips for non-designers
  • Insights
Feb 9, 2021

Five Design Tips for Non-Designers

Key tips for manufacturers and developers unfamiliar with common design principles. Learn more about human factors research, usability and design for medical devices, IVDs and combination products at Emergo by UL.
Helping a person with a walker.
  • Insights
Jan 26, 2021

HFE for Over-the-Counter Medical Devices and Combination Products: Nice to Have or Necessary?

Human factors experts Tamara Will and Tricia Gibo weigh in the necessity of human factors engineering (HFE) work when designing over-the-counter (OTC) healthcare products.
US FDA readies transition plans for COVID-19 medical device enforcement policies
  • Regulatory Update
Jan 25, 2021

US FDA Ramping up Permanent 510(k) Exemptions for Dozens of Medical Devices

Nearly 100 low- and moderate-risk medical devices may soon be exempt from 510(k) premarket notification requirements in the US, according to a new FDA notice.
Flag of Europe
  • Regulatory Update
Jan 21, 2021

European Commission Issues New Guidance on Eudamed Medical Device Database Nomenclature

The European Commission has clarified requirements pertaining to nomenclature medical device manufacturers will use to enter their product information into the forthcoming Eudamed database.
New Brazil INMETRO ordinance eases inspection and documentation requirements
  • News Story
Jan 18, 2021

New Brazil INMETRO Ordinance Eases Inspection and Documentation Requirements

In Brazil, a new ordinance was published by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), providing updated conformity assessment standards and documentation requirements.
Binary numbers as a planet in space
  • Regulatory Update
Jan 15, 2021

US FDA Unveils Next Steps for Regulating Artificial Intelligence-Based Medical Software

US regulators explain evolving approach to oversight of SaMD based on artificial intelligence and machine learning. Learn more about FDA regulation of medical software and healthcare cybersecurity at Emergo by UL.
Canadian flsg
  • Regulatory Update
Jan 13, 2021

Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions

New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater powers for regulatory authorities relating to post-market surveillance and risk management.
European Headquarters
  • Regulatory Update
Jan 13, 2021

European Commission Announces Appointments to Medical Device, IVD Expert Panels

European Commissioners have announced expert panelists for 12 high-risk medical device and IVD categories ahead of MDR, IVDR dates of application. Learn more at Emergo by UL.
Home healthcare products
  • Insights
Jan 13, 2021

Home Healthcare Products Take Center Stage

Increasing utilization of at-home healthcare delivery has implications for how manufacturers develop and design medical device user interfaces.
Picture of a head with gears in it.
  • Insights
Jan 12, 2021

5 Tips to Ease Nervous Participants During Product Evaluations

Tips for reducing nervousness in participants during medical device user research studies to improve feedback.
Drawing of a Wearable insulin pump
  • Insights
Jan 12, 2021

Design with the End User in Mind

Putting the user at the forefront of the medical device design process should start at the very beginning.
Mitigating the risk posed by open and obvious hazards
  • Insights
Jan 12, 2021

Mitigating the Risk Posed by Open and Obvious Hazards

"Open and obvious" use risks in medical products still warrant design efforts that mitigate these risks. Learn more about human factors engineering, design and usability issues at Emergo by UL.
View of London
  • Regulatory Update
Jan 5, 2021

UK MHRA Issues Post-Brexit Medical Device, IVD Registration Requirements

UK regulators clarify post-Brexit registration requirements and deadlines for medical devices, IVDs and related healthcare products. Learn more about UK medical device and IVD regulations at Emergo by UL.
Nurse filling a syringe
  • Regulatory Update
Dec 17, 2020

Cold Chain Management for COVID-19 Vaccines: Ensuring Safe and Effective Distribution

What pharmaceutical, medical device and other manufacturers should consider as vaccine cold chain processes evolve.
Choosing the right tissue model for medical procedure simulation
  • Insights
Dec 14, 2020

Choosing the Right Tissue Model for Medical Procedure Simulation

Selecting appropriate human body surrogates and substitute materials is important for accurate medical device, IVD and combination product usability testing and evaluation.
Flag of Europe
  • Regulatory Update
Dec 2, 2020

Eudamed Actor Module FAQ Now Live

The main reason for an economic operator to register in Eudamed has to do with the Single Registration Number (SRN).
Important considerations for conducting in-home research
  • Insights
Dec 2, 2020

Important Considerations for Conducting In-Home Research

Human factors engineering for medical devices and IVDs is powered by user research, and some key usability results can be effectively obtained by meeting with users in their homes.