ISO 20916: IVD Medical Device Clinical Performance Studies at a Glance
ISO 20916 provides appropriate IVD medical device definitions and insights on the roles and responsibilities of all involved parties and differentiates interventional CP studies.
The European MDR and Human Factors Engineering: Introduction
Emergo by UL's Human Factors Research & Design (HFR&D) experts examine how Europe's MDR affects HFE and usability requirements for medical device manufacturers.
Updated European UDI FAQ Features Revised Compliance Deadlines
The European Commission has published a guide featuring complete timetables that incorporate recent regulatory postponements.
Chinese Regulators Revise Drug-Device Combination Product Registration Requirements
Chinese regulators have updated marketing application requirements for makers of combination products featuring pharmaceutical and medical device components. Learn more about NMPA regulations for combination products, medical devices and IVDs.
Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization
New legislation is being rolled out in stages to match changing European regulations and prepare the ground for a mutual recognition agreement.
European Commission Issues MDR Factsheet for Class I Medical Device Manufacturers
The European Commission has published a new factsheet explaining how the upcoming Medical Devices Regulation (EU) 2017/745 (MDR) will affect manufacturers of low-risk Class I medical devices.
KSA Update: New Saudi Medical Device Regulation, GHTF Applications, AI Requirements, and More
The new regulation retains most of the provisions of the interim regulation and serves as the fundamental basis of the SFDA’s authority to regulate medical devices.
UK MHRA Issues New Guidance on UK REP and Medical Device Regulatory Compliance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain
China Update: Clinical Evaluation Authority, Plus Guidelines for Animal Testing Studies
Chinese regulators plan new unit for clinical evaluation efforts, as well as revise animal testing study guidelines for medical device registrants. Learn more at Emergo by UL.
South Korea MFDS Plans Several Medical Device Regulatory Updates for 2022
The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, plans to roll out several amendments to the country’s Medical Devices Act over the course of 2022, and has also expanded its list of devices eligible for electronic