Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.
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Safety information for medical devices including in vitro diagnostics

Reporting safety, quality, performance issues for medical devices including in vitro diagnostics

Reporting user feedback

If you experience any problems or adverse events related to WHO recommended medical devices including IVDs, please complete the WHO “User feedback form” and send to rapidalert@who.int

User feedback form

Incident reporting by manufacturers to WHO (and NRAs)

Manufacturers must report any incidents related to WHO recommended medical devices including IVDs, please complete the WHO “Manufacturer investigation reporting form” and send to rapidalert@who.int

Incident reporting form

You must submit incident reports for products in the following categories:

Safety notices issued by WHO for devices

WHO Information Notices for device users

WHO reserves the right to issue WHO Information Notices for Users when a threat to public health is perceived. Typically, this is when a device manufacturer does not act or does not appropriately reduce the risk related to use of a device through adequate field safety corrective action. WHO also reserves the right to issue WHO Information Notices for Users to supplement manufacturer-issued field safety notices

Latest update

Safety notices issued by manufacturers and NRAs

Field safety notices (FSNs) issued by device manufacturers

FSNs are issued by manufacturers when a field safety corrective action takes place.

A field safety corrective action (FSCA) is an action taken by the manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a device that is already placed on the market:

  • Return of device to supplier (recall)
  • Device modification (including changes made to labelling and IFU)
  • Device exchange (swap-up)
  • Device destruction
  • Retrofit by purchaser of device according to manufacturer modification/design control

 

 

Safety Notices issued by NRAs

The International Medical Device Regulators Forum maintain links to websites of their members where current safety notices can be found.

Safety information

Currently active FSNs for products recommended by WHO

A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also provide updated information about how an IVD should be used.

Active FSNs