Taiwan’s Ministry of Health and Welfare (MOHW) has issued Announcement No. 1111610130 and Announcement No. 1111606650 (links in Chinese) to commence the public consultations for the abolition of the Requirements for Indicating the Unique Device Identifier on Medical Device Labels (MOHW Announcement No ..read more

I was delighted by the level of interest in Emergo by UL’s Human Factors Research & Design (HFR&D) November 2022 webinar, titled Design and Evaluation of Electronic Instructions for Use. Our human factors specialists Yvonne Limpens and Oliver Cook ably presented on the topic to a large audience, drawing 1,840 total registrants and over 800 live attendees ..read more

A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process that is expected by regulators.  A complete and well-considered URRA helps ensure that all use-related risks are considered and mitigated to an acceptable level throughout the development process ..read more

The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends to reference the definitions of “device” and “counterfeit device” in guidances, regulatory documents and other communications and documents for FDA staff, industry and other stakeholders going forward ..read more

The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products when seeking permission to import or place them in the Malaysian market ..read more

  UL Solutions ComplianceWire® has launched a new release of its training and qualification management system that includes several enhancements and improvements to greatly improve and automate GxP compliance in life sciences. The ComplianceWire® 2022R2 Release features new customizable qualification, compliance and completion dashboards as well as upgraded and expanded reporting tools to help pharmaceutical, medical device and combination product manufacturers manage their regulatory compliance and employee training processes ..read more

A new 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), despite pending expirations of their CE Marking under previous Directives ..read more

Europe’s Medical Device Coordination Group (MDCG) has issued guidance on the responsibilities of Authorized Representatives. The guidance clarifies the role and requirements of an Authorized Representative under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR ..read more

Health Canada issued a notice reminding manufacturers of electronic health record-based medical devices to obtain a medical device license and/or establishment license, as appropriate. The notice also includes links to guidances that may help determine whether an EHR component, accessory or module is a medical device, as well as guidances on risk classifications and authorizations ..read more

The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the considerations on identifying and responding to deficiencies in premarket submissions. The document supersedes the one of the same title issued on November 2, 2000. The revised document further clarifies the content and format of a deficiency letter and includes a new list of examples of deficiencies and applicant responses ..read more