Are You Producing Custom Made Medical Devices?
Many Dental Practices have purchased small amounts of Dental Lab equipment to enable them to quickly fabricate simple appliances such as essix retainers, whitening trays and mouthguards. What many practice aren’t aware of is the legal requirements placed upon manufacturers of Custom Made Devices.
There are certain legislative factors that need to be considered before placing a custom made medical device on the market for patient use, including staff training and the need to register with a competent authority. In this article I will aim to cover the requirements that any Dental Practice will need to fulfil should they wish to manufacture custom made appliances themselves.
In association with the European Society of Aesthetic Orthodontics - ESAO we have created simple fact sheet to help General Dentists and DCPs understand the requirements of the Medical Devices Directives and whether your practice needs to comply and register with the MHRA Medicines and Healthcare Products Regulatory Agency.