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:
- Safety and performance monitoring: The MHRA is building strategic partnerships with NHS England and equivalent institutions in the devolved administrations that will improve the flow of information about the safety and performance of medical devices. A network of medical device safety officers and medicines safety officers will drive continuous improvement within the NHS
- Encouraging innovation: The MHRA is committed to encouraging innovation and is working closely to address any problems identified with the regulatory framework and to engage directly with developers of new medical technologies through its innovation office that opened in 2013. For example, the MHRA is committed to encouraging new stem cell therapies, genomics, regenerative medicines and new diagnostic software. Initial discussions have also been held with notified bodies in relation to using them to help identify new and innovative technologies which may challenge the regulatory system
- Better collaboration with European partners: The MHRA is continuing to build strategic relationships in Europe to strengthen the European regulatory system and the oversight of notified bodies. A number of common and joint working areas have been identified, these include improved processes and tools for post market surveillance and work to develop EU IT infrastructure to underpin collaborative regulatory work
- Unique Device Identifiers (UDIs): The MHRA recognises the value of UDIs in helping to monitor the safety and performance of implantable medical devices. The agency will work with the Department of Health, NHS organisations, the Health and Social Care Information Centre and the Clinical Practice Research Datalink (CPRD) to encourage NHS trusts to implement systems for UDI recording and analysis
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.”
