Consultation Open for Swiss Ordinance Governing IVD Products
The Swiss federal office of public health (FOPH) announced the opening of a public consultation on the draft in vitro diagnostics ordinance (IvDO) and amendments to the ordinance on clinical trials for medical devices (ClinO-MD).
EC MDCG Explains Eudamed Requirements for Actors Under MDR, IVDR
New MDCG Q&A explains Eudamed registration requirements and obligations for actors that do not fall under MDR Article 31 or IVDR Article 28. Learn more at Emergo by UL.
Five Tips to Make the Most of Your Human Factors Validation Protocol Pre-Sub to the US FDA
How medical device and drug companies can take full advantage of presubmission consultations with the US Food and Drug Administration regarding HF validation test protocol reviews.
Canadian Regulators Issue New Reporting Requirements for Medical Device Shortages
Canadian regulators explain reporting content, timeframes and related elements of new regulations coming in March 2022 to better manage medical device supply shortages.
US FDA Seeks Stakeholder Comment on Regulatory Approaches to 3D Printed Medical Devices
US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.
Brazilian Regulators to Allow Sales of COVID-19 Self-Test Kits to Consumers
Brazil's ANVISA offers expedited registration for coronavirus self-test kits for consumer use. Learn more at Emergo by UL.
IVDR Watch: Updated Joint Implementation Plan Targets Risk of IVD Shortages
An updated IVDR joint implementation plan addresses risks to European IVD supplies due to compliance and capacity issues. Learn more about EU IVD regulations at Emergo by UL.
New Guidelines from Japanese Regulators Cover Medical Device Cybersecurity, Remanufactured Devices and MDSAP Reports
Latest guidelines from Japan MHLW and PMDA address medical device cybersecurity, remanufactured devices and MDSAP applications. Learn more at Emergo by UL.
Options for Medical Device Companies to Appeal US FDA Regulatory Reviews and Decisions
FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.
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