Medical Device Regulation

This is intended as a guide only to the new MDR regulations in respect to the manufacture of custom made dental/medical appliances and includes references to the appropriate MDR articles for further reading, available through the following website:

Medical Device Regulation

This guide has been written on behalf of the Orthodontic Technicians Association (OTA) by OTA Secretary James Green.

Permission has been granted for this guide to be distributed out by members of the Dental Professionals Alliance (DPA) to their respective members and anyone else who they feel would benefit from this guidance.

Medical Device Regulation Document:

Download A guide to Medical Device Regulation