The MHRA stands for Medicines and Healthcare products Regulatory Agency and is the regulator of medicines, medical devices and blood components for transfusion in the UK. It is part of the UK’s Department of Health and Social Care (DHSC). The MHRA was founded in 2003 and has its headquarters in London, employing over 8,000 people.
“Our primary goal is to ensure the safety and effectiveness of medical products within the UK. In partnership with the DHSC, we work diligently to fulfil our obligations to patients, public, ministers and Parliament.”*
What does it do?
Approves new medicines and medical devices: The MHRA reviews the safety, quality, and efficacy of new medicines and medical devices before they can be marketed in the UK. This process includes assessing clinical trial data, reviewing manufacturing processes, and conducting inspections of manufacturing facilities.
Monitors the safety of medicines and medical devices: Once a medicine or medical device is on the market, the MHRA continues to monitor its safety. This includes collecting data on adverse events, conducting post-market clinical trials, and issuing safety alerts.
It’s impact on healthcare equipment
It impacts healthcare equipment by maintaining the safety of medical products/devices – which is vital to make sure that hospitals, HCP’s and individuals are the priority when it comes to safety. We have a few stages to run through before our products are approved by the MHRA.
- Getting our device/equipment certified
- Registering our device/equipment with the MHRA
Guidance states that:
"Manufacturers wishing to place a device on the Great Britain market need to register with the MHRA. More information on registrations (including fees) can be found in the MHRA’s registrations guidance."
Surprisingly, there remain some well-known brands of medical seating who are not currently registered with the MHRA – we would recommend that any care organisation, whether care home or hospital, always check that suppliers or manufacturers they intend to work with are correctly registered.