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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Emergency asthma inhalers for use in schools

From 1 October 2014 schools will be allowed to keep a salbutamol inhaler for use in emergencies when a child with asthma cannot access their own inhaler.

Keeping an inhaler for emergency use will have many benefits. It could prevent an unnecessary and traumatic trip to hospital for a child, and potentially save their life. MHRA recommended that the use of emergency inhalers be supported by appropriate protocols; DH and stakeholders such as Asthma UK have developed guidance for schools in England on using emergency inhalers which could form the basis of any school protocol or policy.

This follows a public consultation (external link) where there was overwhelming support for changing the regulations to allow schools to hold an emergency inhaler.