In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions.Following the consultation and…
Guidance on how to report adverse incidents with IVCs. To be read in conjunction with the guidelines on a medical devices vigilance system MEDDEV 2.12/1.
Guidance on how to report adverse incidents with joint replacement implants. To be read in conjunction with the guidelines on a medical devices vigilance system MEDDEV 2.12/1 which sets out…
During the coronavirus pandemic it may not be possible for service personnel or external engineering support to operate as normal. The following options are available to manufacturers and GxP laboratories.If…
OverviewA key part of the agreement on the UK withdrawal from the European Union is the implementation of the Northern Ireland Protocol. The effect of the Northern Ireland Protocol is…
