The following changes are not rated as significant, if they do not require the issuance of a new Certificate:
- Changes not related to design and intended purpose.
- Quality system changes.
- Supplier changes such as adding a supplier of the same material fulfilling the same specifications.
- Manufacturing site changes under same legal manufacturer and following the same manufacturing requirements.
- Organisational changes.
- Exchange of components by an equivalent part to which equivalency was demonstrated.
- Material changes with materials fulfilling the same specifications.
- Limitation / reduction of the intended purpose e.g. due to PMS signals, changes to state of the art.
The following changes are rated as significant:
- All changes where the MDD/AIMDD certificate needs to be updated
- Additional claims in the intended use and/or medical indication.
