Clinical trials: Medical Equipment

Department of Health and Social Care written question – answered on 12th October 2020.

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Photo of Alec Shelbrooke Alec Shelbrooke Conservative, Elmet and Rothwell

To ask the Secretary of State for Health and Social Care, if he will publish the (a) subject and (b) outcomes for each trial of a new medical device developed for the UK market since 1 January 2006.

Photo of Nadine Dorries Nadine Dorries Minister of State (Department of Health and Social Care)

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently bound by the European Union Regulations, the Medical Devices and the In-Vitro Diagnostic Devices Regulations, and its transparency provisions and therefore cannot currently publish information relating to approved clinical investigations from 1 January 2006.

The Medicines and Medical Devices Bill currently going through parliament will give the MHRA the power to update and amend the legislative frameworks that governs human medicines, medical devices and veterinary medicines. These powers will also enable transparency to support patient safety work. Clinical investigations work will be part of these future considerations.

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