Custom made devices

Manufacturers of 'custom made' devices are not required to follow the normal conformity assessment procedures as discussed elsewhere.

'Custom made' means that the product is manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user and it is intended for the sole use of a particular patient.

Examples of professional users are Opthtalmologist, Optometrist, Orbital Prosthetist, Ocularist, Audiology Technicians, Orthotist, Dentist, Hearing Aid Dispenser, Orthopaedic Shoefitter.

Examples of 'custom made' products include dental appliances, artificial eyes/cosmetic shells, maxillofacial prosthesis, hearing aid inserts/moulds.

Manufacturers of custom made devices need to ensure their products meet the relevant requirments and register.

MHRA have produced specific regulatory guidance for manufacturers of these products (Guidance Note No 9 Guidance Notes for Manufactuers of Custom made Devices).


Page last modified: 07 February 2008