PARLIAMENTARY WRITTEN QUESTION
Defibrillators: Sales (4 October 2024)

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the United Kingdom’s medical devices market and works to protect and promote public health and patient safety. We undertake safety and market surveillance of all medical devices in the UK to monitor both performance and safety. We also designate Approved Bodies to undertake conformity assessments of medical devices and award a UK conformity assessed marking to sell products.

The MHRA acts on evidence and takes prompt action where necessary to protect public health. We communicate any actions taken to healthcare professionals and patients as appropriate. We encourage all users of medical devices to report any problems to us via the Yellow Card Scheme.

We are aware of issues raised by stakeholders regarding the CellAED device and we are investigating these concerns with the manufacturer.

Typically, when concerns are identified we have a number of regulatory options available to protect the public including, but not limited to, working with manufacturers to address safety concerns, negotiating a voluntary suspension of sales pending the conclusion of a safety and performance investigation, producing safety communications, or taking compliance action to prevent sales when required.

Interactions between medical device manufacturers and the MHRA are confidential. This is to promote transparent, accurate and timely flow of information to allow appropriate regulatory decisions to be made from evidence provided.