LABELLING OF MEDICAL DEVICES 44. Labelling of medical devices The following particul ...

17.0 In use stability: This section should provide information on in use stability st ...

In use stability: This section should provide information on in use stability studies ...

Sterilization: (i) Where the device is supplied sterile, the dossier should contain t ...

For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

(ii) Evidence of the ongoing revalidation of the process should also be provided. Typ ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...