The new Regulations do not introduce revolutionary changes to the scope, borderline determination or classification of medical devices. The one significant change is a completely new risk based classification system for In Vitro diagnostic devices.
However, for some manufacturers there are likely to be costly and difficult changes. Some of the key changes are:
- The scope is widened to cover non-viable human origin and other non-animal origin biological materials as well as certain devices without a medical purpose.
- Prediction and prognosis are added as recognised medical purposes in the definition of a medical device.
- The borderline between devices and drugs is slightly changed.
- Many new classification rules are added on software, nanomaterials, inhalation devices, substances administered via body orifices and active therapeutic devices with a diagnostic function.