Great Britain
The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
Great Britain
The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.
Great Britain
The article provides a general overview of the UK regulatory framework for clinical investigations related to medical devices intended to be marketed and used in the country.
MHRA
The new article describes in detail the specific requirements an application should meet, as well as the relevant steps and procedures.
MHRA
The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.
MHRA
The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products,...
