MHRA
The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. Table of Contents The Medicines and Healthcare Products Regulatory...
MHRA
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...
MHRA
This article addresses the aspects related to the extensions to the timelines introduced in order to allow marketing products before compliance with the new regulatory requirements will be achieved. Table of Contents The Medicines and Healthcare Products Regulatory...
MHRA
The article provides a general overview of the regulatory requirements for the registration of new medical devices relying on CE certificates that are either expired or about to expire. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),...
Europe
The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...
