
MHRA Guidance on Innovative Devices Access Pathway: Overview
The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.
The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
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...
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published guidance describing the registration process medical devices must go through before placing them on the market in Great Britain...
The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the...