By Stewart Eisenhart, Emergo Group
Healthcare regulators in the UK are now requiring medical device manufacturers and sponsors to register their clinical trials in publicly accessible databases such as the EU Clinical Trials Register or ClinicalTrials.gov in the US.
According to the National Health Service’s Health Research Authority (HRA) division, the new requirement applies to clinical investigations of medical devices, combined pharmaceutical and device clinical trials as well as clinical studies for novel devices. Manufacturers and sponsors must now comply with the registration requirement in order to obtain favorable ethical opinions from Research Ethics Committees (REC) in order to conduct their clinical trials in the UK.
The new HRA requirement went into effect September 30 2013. Regulators expect sponsors who obtained REC ethical approvals prior to that date to also register their trials for best practice purposes. A study sponsor may request an exemption from the registration rule by providing trial and REC information as well as justification for the request to the HRA.
This new rule adds another step to the medical device clinical trial management process in the UK, but does not apply (at least not yet) to other EU member states. It will be interesting to see how many clinical trial sponsors appeal to the HRA for exemption, and whether they’re successful.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.