| (1) | The following are the classes of medical devices and IVDs: |
| (b) | Class B - Low-moderate Risk; |
| (c) | Class C - Moderate -high Risk; |
where risk relates to the patient, user or to public health.
| (2) | Medical devices, except custom made medical devices, and IVDs must be registered with the Council in terms of call up notices before they may be sold or used in the Republic. |
| (3) | The Council must determine the classification of medical devices and IVDs in accordance with the classification rules. |
| (4) | Where the classification of a medical device or IVD is inconclusive and places it in more than one class, or between classes, the Council must, after following the classification rules, place the medical device or IVD in the higher of the risk classes. |
| (5) | The Council must consider the classification of a medical device or IVD individually, taking into account its design and intended use. |
