The supplier must provide a copy of the product labeling. This includes the label, instructions for use, and information related to the identification, technical description, intended purpose and proper use of the product, and other instructional materials provided for users of the product, both professional and laypersons, as appropriate, and for relevant third parties*
Labels must minimally include:
- brand or trade name of the medical device,
- catalog number,
- contact information of the manufacturer,
- recommendations that would reduce sufficiently the risk of use,
- intended use
- handling measures for storage and transport,
- warnings and precautions, and
- particular product conditions (e.g. sterility).
- The instructions for use, where possible, should comply with the principles of labeling for medical devices and IVD medical devices of IMDRF/GRRP WG/N52 FINAL:2019.
* In any of the official languages of the PAHO Region: English, Spanish, French and/or Portuguese.