This post was originally published on our sister blog Inside Medical Devices.
On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015.
The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices. The MHRA hopes that the DEAC will help the MHRA “have stronger links with the wider scientific community to facilitate access to specialist expertise.” The DEAC is expected to be relatively small in size with around 12 members and a chair to enable the group to be more agile and responsive to important regulatory issues concerning medical devices.
The DEAC will be linked to a network of specialist sub-groups and ad-hoc groups. The membership of the sub-groups will be flexible depending on the topics and existing specialist groups.
The DEAC will replace the MHRA’s current expert advisory group, the Committee on the Safety of Devices(CSD). The CSD was temporarily suspended earlier this year. Until the new DEAC is created, an Interim Committee on the Safety of Devices and Transitional Advisory Group will be set up. The Interim Committee will be composed of members of the CSD and will perform the duties of the CSD and support the implementation of the Stephenson Review recommendations, discussed below.
The MHRA’s announcement of the intention to establish DEAC comes as part of the MHRA’s response to recommendations by the Independent Review Group chaired by Professor Terrence Stephenson. Last summer the MHRA asked Professor Stephenson to lead an independent review into how the MHRA can improve its access to clinical advice and engagement with the clinical community. The Stephenson Review made 12 recommendations covering four areas:
- The organisation of clinical advice, input, and leadership.
- Collecting and using device incident data.
- Communications and partnerships.
- Future developments and emerging challenges.
The MHRA accepted all of the Stephenson Review’s recommendations.