Lord Hunt of Kings Heath – 2016 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Lord Hunt of Kings Heath on 2016-02-29.
To ask Her Majesty’s Government whether the Rapid Review Panel process can be extended to medical device technology, and if not, why not.
Lord Prior of Brampton
The Rapid Review Panel’s (RRP) primary remit is the evaluation of products for potential use in the National Health Service, to support claims of improved efficiency or efficacy of infection prevention and control interventions i.e. products that could reduce healthcare associated infections. The RRP, however, does not have the remit to regulate the safety of therapeutic products such as medical devices.
Due to the requirements of safety assurance and regulation of therapeutic products, which are verified through Notified Bodies applying a Conformité Européenne (CE) marking, medical device technology falls within the remit of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA’s Innovation Office is set up to assist companies in the regulation of novel medical devices.
