IMB Position Paper: Manufacturing / Adaption of Splints and Splinting Material by Professional Users
01 May 2007
Manufacturing / Adaption of Splints and Splinting Material by Professional Users
This position paper has been written by the Irish Medicines Board (IMB) to assist in clarifying whether the activities carried out by professional users in relation to splinting are covered by the provisions of the medical devices legislation in Ireland. Splints are usually manufactured or adapted within healthcare institutions by professional users such as physiotherapists and occupational therapists. The activities of adapting and manufacturing splints have different consequences, with respect to the classification of the splints, depending upon the level of adaptation and manufacturing undertaken.