Information to be supplied with medical devices – as a label

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.

ItemInformation to be supplied
1Name and trade name of the medical device or IVD
2The manufacturer’s name, or trading name, and business address
3The applicant’s name and business address
4The approved intended purpose of the medical device or IVD where practical
5The product catalogue code where applicable
6The expiry date where applicable, or date of manufacture
7The Batch code or number and or the lot number where applicable
8The 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
9Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging
10Where appropriate, an indication that the device contains or incorporates a Scheduled or biological substance
11The expiry date where applicable, and if there is no expiry date then the date of manufacture
12Any particular handling or storage requirements applying to the device
13If the device is supplied sterile, an indication of its sterile state and, where appropriate, the sterilization method.
14Where 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
15Any warnings, restrictions, or precautions that should be taken, in relation to use of the device
16The performance intended where applicable
17Any special operating instructions for the use of the device, special facilities, special training or particular qualifications of the medical device user or third parties
18If applicable, an indication that the device is intended for a single use only
19If 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
20If 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
21If the medical device is a reprocessed medical device; the name of the re-processor and identification that the device has been reprocessed