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MHRA ups its game on medical device safety

New independent committee with stronger links to relevant expertise to come on stream within the year

Caroline White

Monday, 21 July 2014

A new committee with stronger links to relevant scientific expertise will be set up within the year to provide independent expert advice on medical devices, such as breast implants and pacemakers, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

The new Devices Expert Advisory Committee (DEAC), which will be up and running before April 2015, replaces the MHRA’s current expert advisory group, the Committee on the Safety of Devices (CSD), which has been in operation for 13 years.

The move is part of the agency’s response to the 12 recommendations made by Professor Terence Stephenson, following a series of high profile safety concerns about devices such as metal on metal hip replacements, breast implants, and vaginal meshes.

Last summer, the MHRA asked Professor Stephenson, who chairs the UK Academy of Medical Royal Colleges, to lead an independent review into how the Agency could strengthen its links with the wider scientific community to enhance access to specialist expertise on devices.

As a result, the MHRA will also be building strategic partnerships with NHS England and equivalent institutions in the devolved administrations to improve the flow of information about the safety and performance of medical devices.

And it will be 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 which opened last year.

It is working with its European partners to strengthen the European regulatory system and the oversight of Notified Bodies. Several common and joint working areas have been identified, including improved processes and tools for post market surveillance and work to develop IT infrastructure to underpin regulatory collaboration.

The MHRA has also recognised the value of unique device identifiers (UDI) 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 Terence Stephenson said he was pleased that the MHRA had accepted all the recommendations his review group had made.

“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,” he added.

John Wilkinson, the MHRA’s Director of Medical Devices, said: “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.”

He continued: “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."

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