The previous system with four classes remains in place. Classification for most products will not change, but there is some revision where the material properties of otherwise unmodified products may lead to classification changes – for example nanomaterials. A number of software products may also be subjected to changes in classification (see question 9).
Furthermore, in a new class of Class I medical devices, manufacturers of reusable surgical instruments are now required to involve a Notified Body for MDR to assist with conformity assessment.
Classification rules can be found in Annex VIII of the new regulation.
Another new provision allows for MDR regulation of some products without medical purpose. The preliminary list of those products can be found in Annex XVI.