Post-market surveillance monitors the continued compliance of WHO-prequalified male circumcision devices (MCDs) products with WHO prequalification requirements. This must include proactive collection of information on quality, safety and performance of the MCD after it has been prequalified, as well as reactive reporting for the notification and evaluation of complaints, enabling appropriate action to be taken.
As soon as an MCD is accepted into the prequalification assessment process, and for as long as that MCD is included in WHO's List of Prequalified MCDs, the manufacturer must, as a condition of prequalification, follow WHO guidance for post-market surveillance of in vitro diagnostics (since it is also applicable to MCDs). It must:
- notify WHO of any events relating to the MCD that have affected (or could have affected) the performance of the MCD, safety of the person being tested, safety of users of the MCD or safety of any person associated with the MCD, including:
- any serious adverse effect, which should be reported to WHO within 10 days
- any moderate adverse event or any change in the trend of mild adverse events, which should be reported to WHO within 30 days
- all complaints (as well as all serious, moderate and mild adverse events), which must be reported to WHO annually in the periodic summary report.
In the case of a complaint, WHO will request the manufacturer to promptly provide further information relating to the complaint, including details regarding the investigation undertaken, and any corrections and corrective actions taken:
- to activate the manufacturer's complaint-handling system, to inform WHO of reportable adverse events, and to encourage end users to report on problems experienced with the use of the MCD
- to notify WHO of all events that require field-safety corrective actions, such as withdrawal of products from sale or distribution, physical return of the MCD to the manufacturer or destruction of the product (e.g. recall), product exchange, product modification(s) or provision of additional advice to customers to ensure that the product continues to function as intended
- if required, to supply sufficient quantities of the prequalified product to WHO, or to laboratories designated by WHO, free-of-charge and delivered duty paid, for post-market surveillance lot verification testing.
WHO will investigate any complaint concerning a prequalified MCD that is communicated to WHO by end users or by manufacturers. (Product complaints can be submitted by completing a product complaint form. (See WHO guidance for post-marketing surveillance of in vitro diagnostics, which is also applicable to MCDs.) First, WHO will notify the manufacturer and, depending on the nature of the complaint, may also notify national regulatory authorities (NRAs), relevant authorities of any interested WHO Member State and/or interested UN agencies of the complaint. WHO reserves the right to use, publish, issue, share with with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (pursuant to certain provisions of this document, including provisions regarding the protection of any commercially-sensitive information of the manufacturer) any outcomes, reports and/or results — whether in draft or final form, and whether positive or negative — of:
- any investigation relating to a complaint concerning any product and/or prequalified product
- any field safety corrective action
- any WHO Notices of Concern, WHO Notices of Suspension or WHO information notices for users
- any manufacturer-issued field safety notices
- any confidential information to which WHO may gain access in the course of any of the foregoing.
WHO will review the investigation conducted by the manufacturer to ensure that it complies with scientific principles and is in accordance with international guidance and standards. WHO reserves the right to request a special inspection to verify that correction and corrective actions have been implemented.