Government Review Proposes Reforms at UK’s MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) should create a registry of devices similar to Australia’s Register of Therapeutic Goods, according to recommendations from an independent review carried out on behalf of the UK government.

Entry on the register should be a condition of selling a device in the UK, and devicemakers should provide details of authorizations that they hold in other jurisdictions, the Independent Medicines and Medical Devices Safety Review advised.

In addition, a separate database of implanted devices would allow the long-term follow-up of patients and provide information on device safety and patient-reported outcomes, the report said.