EU MDR/IVDR
The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on...
EU MDR/IVDR
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document describing the rules on healthcare institution exemption for medical devices. It is important to mention...
MHRA
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance dedicated to the custom-made medical devices and applicable regulatory framework. The scope of the document covers all custom-made medical devices, including the active...
MHRA
The Medicines and Healthcare products Regulating Agency (MHRA) of the UK has updated its guidance for medical device manufacturers initially published in December 2014. In particular, the document provides additional clarifications and recommendations regarding how...
MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published the Target product profile (TPP) for the tests intended for the point of care use to detect the virus SARS-CoV-2 (the “novel...
