To ask the Secretary of State for Health, what rules determine who must sign the statement of manufacture that accompanies a custom-made dental device in the UK at initial and final inspection.
2 March 2015
Annex VIII of the EC Medical Devices Directive 93/42/EC, which is transposed into United Kingdom law by the Medical Devices Regulations 2002 (as amended), specifies that the statement of manufacture for custom-made devices must be drawn up by the manufacturer or his authorised representative. Amongst the information to be provided on the statement is the name of the medical practitioner or other authorised person who made out the prescription against which the custom-made device was manufactured. Article I of the aforementioned Directive defines a custom-made device as meaning any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so which in the case of custom-made dental devices would be a dental practitioner.