Europe
The article provides a brief overview of an updated guidance document issued by the UK regulating authority with respect to software products subject to regulation as medical devices. Table of Contents The Medicines & Healthcare Products Regulatory Agency (MHRA),...
Europe
The new article highlights the aspects related to the review of the application by the authority and regulatory decisions the authority may take based on the results of such a review. Table of Contents The Swiss regulatory agency in the sphere of healthcare products,...
Europe
The new document describes in detail the aspects related to the existing types of clinical trials, as well as the way an interested party should submit an application. Table of Contents Switzerland’s regulating authority in the sphere of healthcare products,...
Europe
The new article describes in detail special projects the authority intends to implement in order to introduce specific needs associated with the products based on innovative technologies. Table of Contents The Medicines and Healthcare Products Regulatory Agency...
Europe
The new article addresses the matters related to the regulatory status of the products based on artificial intelligence technology, regulated as medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK authority in the...
Europe
The new article highlights the aspects related to cybersecurity for software-based medical devices intended to be marketed and used in the UK. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK regulating authority in the sphere of...
