RegDesk Regulatory Roundup

Oct 4, 2023

Understanding Class II Medical Devices : Basic Insights

The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...

Sep 22, 2023

MHRA

MHRA Guidance on IVD Regulations: Overview

The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...