European Commission Issues MDR Q&A Document on Medical Device Clinical Investigations
The European MDCG has issued new guidelines for compliance to clinical investigation requirements under the medical devices regulation (MDR). Learn more at Emergo by UL.
US FDA Publishes Draft Guidance on Distinguishing Between Servicing and Remanufacturing Devices
The document addresses maintenance activities performed on products that have the potential to impact their regulatory status.
US FDA Removes Some Software Functions from Medical Device Classification Regulations
The US food and drug administration adjusted the language in eight medical device classification regulations in a ruling published in the federal register.
TGA Publishes Guidance Documents for Reclassified Medical Devices
Australia's Therapeutic Goods Administration (TGA) provided information on deadlines and transitional arrangements for three of the six medical device categories slated for reclassification on November 25, 2021.
Importers in Northern Ireland Must Comply with MDR Requirements
Medical device and IVD importers active in Northern Ireland must comply with MDR and IVDR requirements, according to updated UK MHRA guidance. Learn more at Emergo by UL.
EU MDR Date of Application Roundup: EMDN, eIFUs, UDI Helpdesk, Clinical Investigation
May 26, 2021 has arrived and the European union’s medical devices regulation (MDR) now governs medical devices (including active implantable medical devices or AIMDs).
New Guidance Published for Medical Device and IVD Cybersecurity Under MDR and IVDR in Europe
European MDCG establishes medical device and IVD cybersecurity framework based on IMDRF recommendations. Learn more about medical device cybersecurity issues at Emergo by UL.
US FDA Updates Final Guidance on ISO 10993 for Medical Device Biocompatibility
Final FDA guidance on ISO 10993-1 for biological evaluation of medical devices gets an update. Learn more about US medical device regulations at Emergo by UL.
US FDA Medical Device User Fees Increase 7% for 2021
FDA user fees for the agency's 2021 fiscal year increase by seven percent, including for small-business applicants. Learn more about US FDA regulatory issues at Emergo by UL.
The European MDR and Human Factors Engineering: Intended Purpose
In the second blog post in our series on human factors engineering and the European Medical Devices Regulation (MDR), we will discuss intended purpose: