Written Questions are submitted by MPs or Lords to receive information from a Department.
|15 Sep 2020, 6:20 p.m.||Clinical Trials: Medical Equipment||Alec Shelbrooke|
To ask the Secretary of State for Health and Social Care, whether all trials using new medical devices are logged centrally; and what steps he is taking to ensure that there is oversight of all non-drug trials.
Answer (Ms Nadine Dorries)
Medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). All trials of new medical devices being developed for the United Kingdom market are reviewed by the MHRA before the devices are used on humans in these trials in the UK. The MHRA maintains a record of all such trials whether approved or refused. Plans are in place to make this information available to the public in future. The MHRA only has oversight of medicines and medical devices trials and therefore do not have oversight of all non-drug trials.
All non-drug trials (including device studies) are centrally reviewed for ethical approval by the Health Research Authority (HRA). If they meet a set of additional legal and policy criteria, they are granted approval to proceed in the National Health Service.
All clinical trials must be conducted in accordance with the Policy Framework for Health and Social Care, which describes the roles and responsibilities of those involved in research oversight.
There is an expectation that all trials are registered and a lay summary made available on the HRA website.