
MHRA Guidance on IDAP Pilot: Application in Detail
The new article describes in detail the specific requirements an application should meet, as well as the relevant steps and procedures.
The new article describes in detail the specific requirements an application should meet, as well as the relevant steps and procedures.
The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.
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) of the UK has published guidance dedicated to the medical device stand-alone software including applications. The scope of the guidance covers standalone software and applications intended to be marketed...