Jun 12, 2023
Europe
The new article highlights the aspects related to the general essential requirements, as well as the ones related to the design of medical devices to be followed in order for the latter to be allowed for marketing and use in the United Kingdom. Table of Contents The...
Read More
Jun 12, 2023
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),...
Read More
May 24, 2023
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...
Read More
May 24, 2023
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...
Read More
May 1, 2023
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...
Read More