Medicines and Healthcare products Regulatory Agency launches independent Devices Expert Advisory Committee to improve regulation of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a new independent Devices Expert Advisory Committee (DEAC) which will be responsible for providing expert advice that helps to regulate medical devices such as hips, breast implants and pacemakers.
The MHRA needs to have a high-level oversight of devices comparable for that of medicines, but designed to reflect the diversity of the products, clinical applications and settings
The new DEAC will replace the MHRA’s current expert advisory group, the Committee on the Safety of Devices (CSD), which has been in operation for 13 years, and will help the agency have stronger links with the wider scientific community to facilitate access to specialist expertise.
The creation of this new group is part of the MHRA’s response to the 12 recommendations made by Professor Terence Stephenson who was last summer asked by the regulator to lead an independent review into how the organisation can improve its access to clinical advice and engagement with the clinical community in relation to medical devices.
The move comes in the wake of the PiP breast implant scandal, in which implants were found to contain non medical-grade silicon.
The MHRA’s response to the recommendations includes:
Professor Stephenson said: “I’m pleased that the MHRA has accepted all the recommendations my review group has made and has made good progress in responding to them.
“The field of medical devices is expanding rapidly and there is increasing complexity of both devices and their clinical applications. The MHRA needs to have a high-level oversight of devices comparable for that of medicines, but designed to reflect the diversity of the products, clinical applications and settings, which are often more complex than those associated with medicines.”
John Wilkinson, the MHRA’s director of medical devices, added: “The MHRA welcomes and accepts all the recommendations made. Independent advice to support our regulatory practices is vital if we are going to continuously improve as a regulator so that patients can be confident about the safety and performance of the medical devices they use.
“We are already making good progress in responding to a number of these recommendations and the new independent Devices Expert Advisory Committee will provide us with high-quality specialist advice.
“We are committed to improving our engagement with the clinical community and building good relationships within Europe, the scientific community, NHS and with the independent sector.”