Information to be provided with medical devices as a label where possible on the medical device or IVD, or on the packaging of each unit or on the packaging of multiple devices or IVDs
The information mentioned in the following table must be provided with a medical device.
| Item | Information to be supplied |
|---|---|
| 1 | Name and trade name of the medical device or IVD |
| 2 | The manufacturer’s name, or trading name, and business address |
| 3 | The applicant’s name and business address |
| 4 | The approved intended purpose of the medical device or IVD where practical |
| 5 | The product catalogue code where applicable |
| 6 | The expiry date where applicable, or date of manufacture |
| 7 | The Batch code or number and or the lot number where applicable |
| 8 | The serial number where applicable. For accessories the serial number may be substituted with a control number, and for software it may be substituted with a version number |
| 9 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging |
| 10 | Where appropriate, an indication that the device contains or incorporates a Scheduled or biological substance |
| 11 | The expiry date where applicable, and if there is no expiry date then the date of manufacture |
| 12 | Any particular handling or storage requirements applying to the device |
| 13 | If the device is supplied sterile, an indication of its sterile state and, where appropriate, the sterilization method. |
| 14 | Where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package |
| 15 | Any warnings, restrictions, or precautions that should be taken, in relation to use of the device |
| 16 | The performance intended where applicable |
| 17 | Any special operating instructions for the use of the device, special facilities, special training or particular qualifications of the medical device user or third parties |
| 18 | If applicable, an indication that the device is intended for a single use only |
| 19 | If applicable, an indication that the device has been custom-made for a particular individual and is intended for use only by that individual or health professional |
| 20 | If applicable, an indication that: (a) if the device is a medical device other than an IVD medical device—the device is intended for pre-market clinical investigation; or (b) if the device is an IVD medical device—the devices is only intended for performance evaluation only (c) the device is intended for non-clinical research, teaching or testing purposes (d) the device is intended for presentation or demonstration purposes (e) the device is for in vitro diagnostic use |
| 21 | If the medical device is a reprocessed medical device; the name of the re-processor and identification that the device has been reprocessed |