The definition of a medical device does not change significantly and thus the scope of the Regulation is almost identical to the Directive that it replaces. However, new medical purposes are added such as prediction and prognosis. A major conceptual change in the scope is the addition of specifically listed devices that have no medical purpose. This also adds a new borderline within the regulation itself.
The Regulation would have given an opportunity to provide definitions of pharmacological, metabolic and immunological modes of action. This did not happen, so borderline definition between medical devices and medicinal products remains problematic. The possibilities for arguing in favour of the medical device status have nevertheless been reduced somewhat, which could result in some medical devices currently on the market becoming medicinal products (drugs).
The classification system remains substantially the same as in the Directive although some devices are moving to a higher class (e.g. all joint implants into Class IIII). New rules have been added for software, therapeutic devices with a diagnostic function, nanomaterials and absorbable devices introduced via a natural body orifice.
A completely new risk based classification system has been established for IVD products.
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK