Defining orthopaedic and dental medical devices
Orthopaedic and dental devices are generally characterised as devices intended to treat or reconstruct skeletal or dental tissue. The scope of orthopaedic and dental devices range from the lowest risk classification (such as reusable instruments) to the highest risks classification, for example total joint replacements, resorbable devices, orthobiologics and device/drug combination devices.
For further clarity and more detailed information on orthopaedic and dental medical devices, please reference the MDR (EU) 2017/745 for EU and The Medical Devices Regulations 2002 (as amended) for Great Britain.
