Application process Additional approvals EU CTIMPSCommercial research

Additional external approvals is required from the MHRA if the research involves the use of medicines or medical devices and the practical and safety issues will need to be addressed before the project starts with the Pharmacy and Medical Engineering Department which are responsible for these aspects of safety.

 

Additional internal safeguards are also required for projects involving ionising radiation, patient data or human tissues.

 

The R&D Department has regular contact with all these organisations and can help ensure that all external and internal approvals are properly managed.

 

Projects involving medicines

 

Approval in principle by the MHRA as well as internal approval on matters of practicality by the Trust's pharmacy department. It is best to consult pharmacy at an early stage when designing a study.

 

Projects involving medical devices

 

Approval in principle by the MHRA as well as internal approval on matters of practicality by the Medical Engineering Department for the use of devices.

 

> Medical devices

 

What is a medical device?

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007, which amended the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, defines a 'medical device' as:

 

any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

 

Projects involving ionising radiation

 

Will require approval by the Radiology Department or the Wolfson Brain Imaging Centre.

 

 

Projects involving patient data

All studies involving the use of patient data must be reviewed and approved by Data Protection Department.

 

 

 

 

See also:

> Projects involving radiology

> Tissue samples

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