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Request for BACN members to join the Central Alerting System

The Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health and Social Care (DHSC) are responsible for the regulation of medicines and medical devices. There are changes being introduced by May 2020, which mean that some products that do not have an intended medical purpose will be required to comply with the new regulations for medical devices. Examples of the types of products impacted include:

  • Contact lenses-eye products
  • Laser skin treatment
  • solid body contour modifying implants (e.g. horn implants)
  • dermal fillers
  • body sculpting equipment and
  • external brain stimulation products.

Further information about these changes can be found here.

For these upcoming changes mean that MHRA need to:

  • ensure manufacturers of such products are aware of the requirements around registering these products
  • put a system in place to share safety information about such products – for example, in the event of a recall.

MHRA propose to hold a database to be contacted via the Central Alerting System so that if they have cause to issue an alert or safety information on such a product, they can share that information with users of these products.

To register, please download the form here or go to the BACN member's area, and find the documents under the resources page via 'Medicine Management'.

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